Pilot Study Program
Abstracts
Pregnant African-American Women's Perceptions of Stressors and Resources that may Impact Preterm Birth.
PI Carmen Giurgescu, Barbara Dancy
Background: In 2005 more than 500,000 infants in the United States were born prematurely, costing 26.2 billion dollars. Persistent disparities exist in relation to preterm birth both nationally and in Chicago, with African-American women having almost twice the rates of preterm birth as non-Hispanic white women. Recent studies suggest that cumulative exposures to environmental stressors such as impoverished, unsafe neighborhoods and perceived racism, may cause a heightened stress response and thus contribute to preterm birth among this group of vulnerable African American women.
Purpose: The purpose of the proposed study is to explore pregnant African American women’s views of stressors, resources, and emotional stress responses that may impact preterm birth. The research questions include: 1. What are pregnant African American women’s perceptions of stressors that impact preterm birth?; 2. What are pregnant African American women’s perceptions of resources that are protective for preterm birth?; 3. What are pregnant African American women’s perceptions of emotional stress responses that may impact preterm birth?
Method: A qualitative, exploratory, cross-sectional design will be used with focus groups. Twenty-five African American women will be recruited from a medical center that serves a predominately low income African American sample. Women who meet the following inclusion criteria will be recruited: 18 years of age or older; singleton pregnancy, and less than 37 weeks gestation. Data about birth outcomes will be collected from the sample through a telephone interview after delivery and medical records.
Outcome: This qualitative community based study will provide critical data on pregnant African American women’s views of factors related to preterm birth and guide the development of a culturally relevant intervention to reduce preterm birth in this vulnerable population.
Testing the Feasibility and the Effectiveness of the "Be Connected" Mental Health Promotion Program for KAAs and their Parents.
PI Heeseung Choi , Barbara Dancy, Eunice Lee, Louis Fogg
The present study uses a two-group, controlled randomized design to determine the feasibility and effectiveness of the culturally and developmentally relevant mental health promotion program (MHPP), “Be Connected” for Korean American adolescents (KAAs) aged 11 to 13 years and their parents. Changes in family structure and role caused by immigration process and related stress result in poor P-C communication, P-C conflicts, and P-C dissatisfaction among KAAs and their parents. The inadequate P-C relationships placed them at increased risks for mental health problems. However, they have not benefited from existing intervention programs as well as mainstream mental health care services due to language barriers and cultural incompatibility. Guided by the Social Cognitive Theory and the Social Ecology Theory, the 4-week MHPP “Be Connected” is designed to improve P-C communication, decrease P-C conflicts, and increase P-C satisfaction by increasing knowledge, parental self-efficacy, and filial self-efficacy among KAAs and their parents. The long-term goal of the “Be Connected” MHPP is to promote KAAs’ mental health, fewer episodes of depression, aggression, and cigarette smoking among KAAs.
Two sampling strategies will be used to identify prospective participants for this study: a random sampling strategy and a convenient sampling strategy. Feasibility of this 4-week program will be assessed by examining recruitment and retention rates and participants’ feedback on acceptability of the program. We will determine the effectiveness of the program by comparing the intervention (n = 15 families) and attention control groups (n = 15 families) on changes in mediating (knowledge, parental self-efficacy, and filial self-efficacy) and immediate-outcome variables (P-C communication, P-C conflicts, and P-C satisfaction) immediately post-test and at 1 month post-intervention. Chi-square tests for categorical variables and t-tests or ANOVA for continuous variables will be used to determine differences between the intervention group and control group. A series of three hierarchical random regression models for the three outcomes, using the SAS PROC MIXED program, will be performed with two factors: one within-subject effect (time–baseline, immediately post-test, 1 month post-intervention) and one between-subject effect (treatment group–"Be Connected" or Control). Hypotheses will be tested by examining the group-time interaction term.
If the present study shows that the “Be Connected” MHPP, the very first MHPP developed for KAAs and their parents in the U.S., is acceptable, feasible, and effective for KAAs and their parents, we will test the long-term effectiveness of this intervention to promote KAAs’ mental health.
Vitamin Effect on Inflammatory Responses and Memory.
PI Hala Darwish, Teresita Briones
Age-related cognitive decline is related to increased inflammatory response secondary to ageing process. Research showed that Vitamin D has anti-inflammatory action and a positive impact on cognitive function. Elderly with diminished memory performance or mild Alzheimer’s disease have low vitamin D levels. In this study we will test the effect of vitamin D supplementation on different types of memory and inflammation in aged rats. Determining the effectiveness of Vitamin D in attenuating cognitive decline and inflammation associated with ageing will help prevent cognitive problems and physical frailty associated with ageing and promote healthy life style among older adults.
Childhood Sexual Abuse and Health: Meaning Making in the Contexts of Race/Ethnicity and Sexual Orientation.
PI Laura Szalacha, Tonda Hughes, Cheryl Parks
Lesbians and women of color are two of the six U.S. population groups identified by Healthy People 2010 as suffering from substantial health disparities (USDHHS, 2000). While ample research has documented heightened vulnerability of sexual minority women and of racial/ethnic minority women, few studies have examined the potentially additive or interactive effects of living with these two marginalized and stigmatized statuses. Childhood sexual abuse (CSA) is a major social problem, with rates in community samples of women typically between 20% and 38%. CSA is associated with multiple long-term negative health consequences, such as anxiety, depression, sexual and relationship problems, risky sexual behaviors, eating disorders, substance abuse and suicidality. Although women who self-identify as lesbian report high rates of CSA as well as high rates of many physical and mental health problems that have been associated with CSA, very little research on CSA among lesbians has been done, and no studies on CSA have been conducted with racial/ethnic minority lesbians. Thus, our specific aims are to: (1) Conduct life-history interviews with African American, Latina, and White lesbians, to explore the intersections among CSA, race/ethnicity, lesbian sexual orientation, and health; and (2) Use existing quantitative data from the Chicago Health and Life Experiences of Women (CHLEW), to t est emerging hypotheses derived from the qualitative interviews about relationships among CSA, race/ethnicity, sexual orientation, and health outcomes.
We propose a mixed-method research design that incorporates new data from in-depth, qualitative life history interviewing with existing longitudinal survey data from the CHLEW study. The project will take advantage of the unusual opportunities afforded by the CHLEW, including its longitudinal design, high retention rates, large sample, racial/ethnic and socioeconomic diversity, and the wealth of data already collected on CSA and health. The broad scope of the existing quantitative data, together with new in-depth qualitative data, will greatly enhance understanding of lesbians' responses to CSA, including health risks and behavioral outcomes and the influence of race/ethnicity and sexual orientation on these outcomes. This information is critical for explicating similarities and differences in health risks across various subgroups of women and for developing culturally appropriate interventions. Data from this pilot study will be used in the development of a larger proposal focusing on CSA and health among sexual minority women.
Breast Cancer Risk Perception and Surveillance Behaviors among High Risk African American Women.
PI Janice Phillips , Julie Zerwic
Despite the many advances, in breast cancer detection, diagnosis, and treatment, African American women are more likely to die from the disease. Overall while African American women have a lower incidence of breast cancer, however AAW under age 40 have a higher incidence. Regardless of age, AAW American women are more likely to die from the disease. To date there are no established preventive measures for breast cancer; however the greatest hope for reducing breast cancer mortality and improving breast cancer survival lies in early detection and prompt follow-up treatment. The aims of this study are to describe the experience and meaning of breast cancer risk for high risk (personal history of breast cancer, family history of breast cancer, positive BRCA 1 and BRCA 2 mutation) African American women age 40 and under. In
conducting this research, the investigator seeks to gain greater insights and understanding what it means to an African American woman considered to be at high risk for developing breast cancer. Using phenomenology, the specific aims are: 1).Obtain descriptions from African American women themselves
known to be at high risk for developing breast cancer the meaning of their risk status and their experiences related to ongoing surveillance. 2).To illuminate the meaning of African American women’s experience of living with a known risk for developing breast cancer. 3).To describe high risk African American women’s perspectives on managing their risk status and related surveillance recommendations.
The proposed study extends previous research by providing a more detailed and explicit description of the actual experience of living with a known risk for developing breast cancer. A growing body of literature indicates that meanings of the cancer experience may prove helpful when designing effective strategies
aimed at improving cancer related outcomes. No studies were located using phenomenology to explore the meaning breast cancer risk for AAW age 40 and under. Notably, this population of AAW experiences the most virulent type of breast cancer as well as the highest incidence of breast cancer. Findings from the proposed study may assist in the design of interventions aimed at reducing psychological distress, addressing inadequate risk perceptions as well as enhancing adherence to recommended surveillance guidelines.
Quality of Life in People Receiving Allogeneic Islet Transplantation for Type 1 Diabetes.
PI Eileen Hacker, Ali Cinar, Joan Martellotto, Jose Oberholzer, Lauretta Quinn
Type 1 diabetes is a chronic medical disorder affecting 1.4 million individuals in the U.S. Type 1 diabetes is characterized by the inability to produce insulin leading to a wide range of complications including cardiovascular disease, retinopathy, neuropathy, and nephropathy. Allogeneic islet cell transplantation, a relatively recent development, is a cell-based therapy that promises to restore insulin function. The potential benefits of this treatment, insulin independence and prevention of hypoglycemia, need to be weighed against the adverse side effects associated with long-term immunosuppressive therapy. Because both the disease and the treatment have the potential to impact important aspects of patients’ lives, it is crucial that quality of life outcomes be examined. This is particularly important for patients considering allogeneic islet cell transplantation if the recognized improvements in metabolic control do not translate into quality of life improvements that are discernable to patients. The specific aims of the study are to: 1) Examine the trajectory of changes in quality of life outcomes during the first 6 months after the initial allogeneic islet cell transplant; 2) Conduct a preliminary examination of the interrelationships among glycemic variability, fatigue, fear of hypoglycemia, physical activity, general health perceptions, and overall quality of life; and, 3) Determine the ability and willingness of subjects to simultaneously wear a continuous glucose monitoring system and wrist actigraph for collection of glycemic variability and physical activity data, respectively. Wilson’s and Cleary’s Revised Model of Patient Outcomes will be used to guide the study. This descriptive pilot study will use a prospective, longitudinal design to measure quality of life outcomes prior to islet cell transplantation and at 1 week, 1, 3, and 6 months following the initial infusion of islet cells in 15 consecutive subjects receiving allogeneic islet cell transplantation. The main research variables include glycemic variability, fatigue, fear of hypoglycemia, physical activity, general health perceptions and overall quality of life. Subjects will be recruited from an academic medical center that is an NIH funded Islet Cell Resource Center. The Medical Center’s Endocrine clinic serves a vulnerable population that is primarily low-income and includes 40% African Americans, 40% Hispanics, and 20% other. The findings from this study will be used to design a larger study to examine the trajectory of changes and interrelationships among quality of life outcomes over a three-year period.
Breast Cancer Knowledge, Attitudes, Beliefs, and Screening Practices among First-generation Immigrant Muslim Women.
PI Memoona Hasnain, Usha Menon, Carrol Ferrans, Laura Szalacha
Purpose: This two-stage project seeks to increase utilization of mammography by first-generation, immigrant Muslim women – a fast-growing, under-studied, and underserved vulnerable minority in the USA and in Illinois. Evidence indicates that immigrant Muslim women underutilize breast cancer screening; they are less likely to report ever having done breast self-examinations (BSE), or had clinical breast examinations (CBE) or mammography, than women in the general United States population. Contributing factors include beliefs about cancer and cancer screening as well as the lack of culturally appropriate communication and services. In order to develop culturally appropriate interventions aimed at increasing mammography use among immigrant Muslim women, a critical first step needed is to better examine predictors of screening behavior. The purpose of this study is to conduct a cross-sectional survey designed to establish screening practices and to identify predisposing, enabling, and need variables, including religious and cultural factors, associated with mammography use by first-generation immigrant Muslim women.
Methods: Two existing surveys and input from key informants via focus groups will guide initial survey development. After translation into Urdu, Hindi, and Arabic, languages spoken by a majority of the target population, the survey will be further refined through cognitive interviews. The survey will be administered, through an in-person or phone interview, to a community sample of study-eligible participants (n=250). Psychometric properties of all scales used in the survey will be assessed by factor analyses and by estimating internal consistency reliability (Cronbach’s alpha). Descriptive analyses will be used to describe sociodemographic information, knowledge, attitudes and beliefs, and frequency of participation in BSE, CBE and mammography. Contingency table and multiple regression analyses will be used to explore associations between enabling, predisposing, and need variables and the primary outcome, mammography use.
Anticipated Outcomes: The findings of the proposed study will shed light on current screening practices and the predictors of mammography use by immigrant Muslim women. Phase I findings will allow the PI to seek additional funding for developing and testing the feasibility, acceptability, and effectiveness of a culturally appropriate intervention aimed at enhancing mammography use by the target population.
Relevance: Breast cancer disparities necessitate examining and addressing factors that hinder the use of early detection services among minority women. A significant proportion of immigrant Muslim women have never or rarely been screened for breast cancer. Hence, there is an urgent need to identify and address barriers to the optimal utilization of mammography screening programs by this group.
Nurse Managed Cognitive Behavioral Therapy for Insomnia in People with COPD.
PI Mary C. Kapella, David Carley, James Hertegen
People with chronic obstructive pulmonary disease (COPD) often go into a downward spiral of decreased activity and deconditioning. Two commonly reported symptoms that interfere with daily activities in people with COPD are dyspnea and subjective fatigue and previous research suggests that poor sleep quality may lead to subjective in people with this disease. In our sample of 130 people with moderate to severe COPD the most frequently reported sleep disturbances on the Pittsburgh Sleep Quality Index were not getting to sleep within 30 minutes and waking up in the middle of the night or early morning. Although there is a substantial body of research in obstructive respiratory disease focusing on sleep apnea and nocturnal hypoxia, little research is focused on the vulnerable population of older people with chronic illnesses and insomnia. The purpose of this study is to examine the feasibility of a classroom-based cognitive behavioral therapy (CBT) intervention for insomnia in people with COPD and preliminary effects of the intervention on sleep quality, fatigue, functional performance, and mood. Specific aims of the study are to: 1. Refine a multistep screening process to identify people with moderate to severe COPD who have insomnia without other significant sleep disorders; 2. Refine a cognitive behavioral intervention for insomnia for people with moderate to severe COPD; 3. Conduct a preliminary examination of the effect of CBT for insomnia on two primary outcomes: a) sleep quality and b) fatigue and two secondary outcomes: a) functional performance and b) mood (anxiety and depression). This pilot study will use a one-group prospective, repeated measures design to evaluate the feasibility of a cognitive behavioral therapy intervention for people with COPD. The initial classroom-based intervention will continue for six weeks, one 1.5 hour session per week. Outcome variables will be measured at two time periods: (b) baseline (time 1); (b) At the end of the intervention period (time 2). The sample will consist of five people with moderate to severe COPD and insomnia. This study will provide preliminary data for a larger, two-group, randomized controlled intervention study. The long-term goal for the research is to yield information regarding effective interventions to improve sleep quality and minimize fatigue in people with COPD. Effective interventions could lead to improved ability to perform important and valued daily activities and improved quality of life.
Activity Space Measurement Study (ASMS)
PI Shannon Zenk, Carol Braunschweig, Barbara Israel, Angela Odoms-Young, Amy Schultz, JoEllen Wilbur
Obesity is a significant public health threat, with 33% of U.S. adults obese and another 29% overweight. Vulnerable populations that include African-American and low SES groups appear to be at greatest risk for being overweight and obese. To reduce and eventually eliminate racial/ethnic and socioeconomic disparities in obesity and related diseases, it is critical to identify and address factors that contribute to energy imbalance, resulting largely from a combination of poor dietary practices and insufficient physical activity, and consequently excess body weight among vulnerable urban populations. The contributions of the environment to obesity are of growing interest. However, studies to date have likely underestimated the role the environment plays in health behaviors and obesity, and related disparities, by focusing solely on neighborhoods where people live (personal residential neighborhoods), instead of the broader spaces in which individuals routinely travel to engage in activities (activity space). Measuring aspects of activity-space environments could provide new insights into environmental contributions to racial/ethnic and socioeconomic disparities in obesity and related health behaviors and diseases. However, little is known about the feasibility of the intensive data collection approach required to capture individuals’ activity spaces and concurrently health behaviors. The purpose of this study is to pilot-test multiple (4 or 7) days of data collection with 40 urban African-American and White adults using (a) portable global positioning system (GPS) units and travel diaries to measure activity space, (b) pedometers to measure physical activity, and (c) 24-hour recalls to measure dietary intake. The specific aims are the following: (1) to examine the feasibility of the data collection approach, including the overall adherence rate for each data collection method and barriers or challenges participants encounter that make it difficult to comply; (2) to compare adherence rates for 4 vs. 7 days of data collection; and (3) to derive measures of activity-space size and key environmental resources/risks, and compare these measures based on: 4 vs. 7 days of data collection, source of activity data (GPS vs. travel diaries), and (activity-space measure (daily path area vs. standard deviational ellipse). The study will be conducted in close collaboration with the Healthy Environments Partnership, a community-based participatory research (CBPR) collaboration in Detroit, Michigan. African-American and White adults participating in HEP’s pilot intervention and who meet the inclusion criteria will be invited to participate in the proposed study. Our goal is to obtain 20 African-American (10 men, 10 women) and 20 White (10 men, 10 women) participants. Results of this study will inform a larger scale study to examine relationships among individual sociodemographic indicators, activity-space environmental resources/risks, health behaviors, and obesity/obesity risk in a population-based sample of urban adults.
Self-Concept Disturbances and Alcohol Use in Preadolescent in Urban Youth: A One-Year Follow-Up Study
PI Colleen Corte, Laura Szalacha
An impoverished self-concept (one comprised of few positive and many negative core domains of self-definition called self-schemas) and a drinking-related self-schema has been shown to distinguish young adults with early-onset alcohol dependence from controls (Corte & Stein, 2005). Whether these self-concept disturbances contributed to the development of alcohol problems is unknown. To address this, we are collecting data (N =37 to date) on 9-12 year old vulnerable urban youth to examine relationships among self-schemas, known risk factors for alcohol misuse (conduct problems and parental alcohol problems), and alcohol use. Preliminary findings suggest that despite their young age: (1) children with (versus without) parental alcohol problems have an impoverished self-concept--both fewer positive (11.1 vs 15.4, p =.05) and more negative (8.3 vs 4.1, p =.01) self-schemas, (2) 19% of these children have a future-oriented drinking-related self-schema (drinking-related possible self), and of those, 29% reported drinking, and (3) conduct problems are associated with drinking, r (37)=.66. The purpose of the proposed study is to complete a one-year follow-up of these youth to examine relationships among these variables over time as pilot data for a larger-scale (RO1) study. Measures include the Harter Self-Perception Profile (Harter, 1985) for the number of positive and negative self-schemas, Antisocial Behavior Checklist-Youth (Zucker et al., 1996) for conduct problems, Children of Alcoholics Screening Test (Hodgins et al., 1993) for parental alcohol problems, Drinker Possible Self Scale (Corte & Stein, 2005; Stein, Roeser & Markus, 1998) for drinking possible self, and Alcohol Use & Misuse Questionnaire (Shope et al., 1994) for alcohol use. Longitudinal studies are essential to determine whether an impoverished self-concept and a drinking-related possible self contributes to early drinking and formation of a drinking related self-schema that motivates alcohol misuse. Ultimately, nursing interventions aimed at altering the self-concept can be developed to prevent alcohol use and misuse in youth.
In Vivo Quantitative Ultrasound Assessment of the Rat Cervix.
PI Barbara McFarlin, William D. O'Brien Jr., Michael J. Oelze, Rita Miller, Rosemary White-Traut
The incidence of preterm birth in the United States has risen 16% since 1990 (Hamilton, Martin, & Sutton, 2004). In Illinois, the incidence of preterm birth was 11.8% in 1992 and has increased to 12.6% in 2002. African-American women are particularly at risk with incidences of 17% compared to 11% in White women (Hamilton, Martin, & Sutton, 2004). In 2002, 19% of all live births to African-American women in Chicago were born preterm. Labor has two major phases: the long conditioning phase of cervical ripening (collagen remodeling), and the active phase of extensive uterine activity that results in cervical dilatation. The latter phase is probably irreversible (Caritis, 2005; Ingemarsson & Lamont, 2003; Pryde, Janeczek, & Mittendorf, 2004). Prevention programs and pharmacologic agents have focused on controlling the active phase of extensive uterine activity, rather than cervical ripening. Our preliminary research developed, tested and demonstrated the feasibility of a new ultrasound technique that detected cervical ripening in the rat ex vivo (after the rat is euthanized, the cervix is excised). The new ultrasound technique utilizes echoes from the quantified ultrasound backscattered signals to yield unique tissue microstructure characteristics that are related to the ultrasound scattering sources. Specifically, the processed data yields three quantified tissue-based parameters: scatterer diameter, scatterer acoustic concentration, and scatterer strength factor. Each of these parameters uniquely characterizes different aspects of tissue microstructure. The initial findings detected significant changes in the pregnant rat ex vivo, as the pregnancy progressed towards delivery, using a discriminant function model to predict group assignment for rats of known gestational age. To utilize this ultrasound technique in humans, it is essential that an in vivo methodology be developed. The goal of this research is to provide pilot data to demonstrate that it is possible to obtain quantitative ultrasound and attenuation data with a 40-MHz miniature vaginal transducer on the rat in vivo (with the rat alive, under anesthesia). Once this study is completed and feasibility has been demonstrated, the goal is to apply for an NIH RO1 grant to study a larger sample of rats in vivo with transducers at 10, 20, 30, and 40-MHz, in preparation for human studies. Thus, the long-term goal of my research program is to develop a non-invasive ultrasound method to quantify cervical ripening in women and to identify initiation of preterm labor prior to the irreversible active phase, so that interventions can be developed to reduce the incidence of preterm birth.
Estrogen Effect on Norepinephrine-elicited Hypertrophy in Neonatal Rat Ventricular Myocytes.
PI Dorie Schwertz
The incidence of heart failure (HF) increases with age. The yearly cost of the disease in the USA is estimated to be over 10 billion dollars. The incidence of HF is lower in premenopausal women than age-matched men. However, in the postmenopausal years, the incidence increases and exceeds that of men making it the #1 killer in this vulnerable population. The results of many human and animal studies suggest that estrogen exerts a protective effect against pathological cardiac hypertrophy (CH) and HF. Research suggests that cellular calcium (Ca2+) overload is central to the development of CH and HF. Virtually all of the key biological signaling molecules involved in development of CH and HF, e.g., norepinephrine (NE), initiate signal transduction via G-protein-coupled (GPC) receptors and elevate intracellular Ca2+. It has been demonstrated chronic NE stimulation acting alone, can produce heart muscle cell hypertrophy and programmed cell death, that transitions into HF. NE binds to 4 GPC adrenergic receptors (ARs - a1A-AR, a1B-AR, ß1-AR, and ß2-AR) and each of these receptors differentially modulate (increase or decrease) intracellular Ca2+. The long-term goal of our research is to elucidate underlying physiological mechanisms that contribute to the cardioprotective effects of estrogen. In this study, we will use a cultured neonatal rat ventricular myocyte (NRVM) model to begin to examine the overall hypothesis that estrogen-elicited alteration in the expression of ARs mediates protection against CH and HF. Aims include: 1) to begin to determine the effect of estrogen on AR expression, 2) to validate a model of NE-induced heart muscle cell hypertrophy in NRVMs, and 3) to demonstrate an estrogen-elicited reduction of the NE-induced hypertrophic response in NRVMs. Pilot data derived from the study will position us to apply for RO1 funding to address the question; whether estrogen-mediated alterations in AR expression are correlated with a reduction in NE-induced hypertrophy, programmed cell death (a m arker of HF) and are responsible, at least in part, for estrogen-elicited cardioprotection.
Neighborhood Influences on Acculturation, Social Alienation and Depressed Mood for Immigrants from the Former Soviet Union.
PI A. Miller, D. Birman, S. Zenk, E. Wang
The purpose of this study is to identify neighborhood characteristics that are associated with acculturation, social alienation, and depressed mood for an existing cohort of 219 recent immigrants from the former Soviet Union. Specific aims are: 1) Describe objective and perceived characteristics of neighborhoods in which participants reside; a) Describe objective social and economic neighborhood characteristics (neighborhood composition, ethnic density, language usage, SES, community amenities) of the neighborhoods in which participants live, using selected indicators from the decennial census and other publicly available data sources; and b) Describe perceived neighborhood social cohesion using self-reported information (social efficacy, sense of community); 2) Examine relationships among objective and perceived neighborhood characteristics, acculturation (English language acquisition; American and Russian behavior), social alienation (social support, alienation), and depressed mood. Indicators of objective neighborhood characteristics will be obtained through public domain databases for participants of our longitudinal study of acculturation and health based on their current place of residence. New information regarding perceived neighborhood social cohesion and updated information regarding acculturation level, social alienation, and depressed mood will be collected from the cohort through mailed questionnaires. This study will provide preliminary data and a model of data analysis for a Competing Continuation Study proposal to NICHD in March, 2006, and a new interdisciplinary cross-cultural proposal of this and other immigrant groups residing in metropolitan Chicago planned for Fall 2006.
Physiologic Effects of Maternal Voice on Preterm Infants
PI M. Bozzette, B. Puppala
Infants born prematurely are exposed to a multitude of sounds and sensations in the neonatal intensive care unit (NICU) that are unfamiliar and stressful and may predispose these infants for developmental delay. As many as half of the premature infants born show some delay in cognitive, perceptual, and sensory processing by school age. Since sensory input is critical during this period of early and rapid neurological development, it is thought that providing a type of stimulation normally experienced in the womb may help reduce developmental delays. A taped recording of the mother’s voice, which can be provided at regular intervals, has the potential to replace one of the intrauterine sources of sensory stimulation for premature infants.
The purpose of this study is to examine preterm infants’ physiological responses to taped maternal voices over time. Twelve premature infants born between 26 and 30 weeks gestation and requiring ventilation support will be examined in this pilot study. Enrollment will begin between the first and third day post-birth, when the infant is stabilized on support. The physiologic variables of heart rate and oxygen saturation as well as body movement will be continuously monitored over each 50-minute data collection segment. Salivary cortisol levels will be measured pre- and post-maternal tape once each day of the intervention. Regression analysis of change over time will be conducted for physiologic measures taken at baseline (20 minutes), during maternal audiotape (10 minutes), and post-tape (20 minutes). These data collection segments will be repeated 3 times each day that the infant receives assisted ventilation (for up to 5 days). In addition, this pilot study will examine the feasibility of using transcranial Doppler sonography to measure and detect changes in cerebral blood flow in response to taped maternal voice. This technique is new and has the potential of providing additional neuro-developmental information on this population. Four randomly selected infants will be examined for changes in cerebral blood flow. Taped maternal voice input has the potential to provide continuity of sensory experience for this vulnerable population. This pilot study will be conducted to derive preliminary data for submission of a large intervention trial to test taped maternal voice intervention for hospitalized premature infants. The long-term goal of this research program is to determine ways to promote normal developmental processes during critical stages of infant development and to facilitate the early mother-infant relationship.
Physical Activity Instrument for Persons with Spinal Cord Injury
PI E. Collins, E. Langbein, S. Foley
Many of today’s chronic health problems are associated with low levels of physical activity. Individuals who sustain a spinal cord injury (SCI) become more sedentary. Recently, there has been a surge in research to delineate the relationship between physical activity and health status in the able-bodied. There has been no similar surge in research for the disabled. Major epidemiological studies have not included persons with physical disabilities. This is due in part to a lack of valid survey instruments to measure physical activity in the SCI population. There are no large data sets on physical activity in persons with SCI, nor are there any data on the long-term benefits of physical activity in this population. It can be concluded that, at the present time, there is no evidence regarding the role of physical activity in promoting and sustaining health in persons with SCI that is comparable to what is available for the non-disabled. The specific aim of this project is to establish a reliable and valid physical activity inventory for people with SCI (PAI-SCI). The PAI-SCI will be based on the Physical Activity Scale for Individuals with Physical Disability (PASIPD). Seventy-two subjects with SCI (36 paraplegic and 36 tetraplegic) will be recruited to complete the physical activity questionnaire. Test-retest reliability will be completed. Validity of the instrument will be determined using two methods. (1) Subjects will complete the physical activity questionnaire. They will then complete a one-week physical activity diary (using a voice-activated tape recorder). Physical activity will be reassessed at the end of the week. A Pearson-r correlation will be used to determine the relationship between the activity diary and the physical activity instrument. (2) We will complete Rasch analysis on the PAI-SCI. Rasch analysis will yield reliability and validity information as well as determine which items best discriminate between those who are physically active versus not. The long-term aims of this research program are to (1) use this instrument to identify the physical activity requirements for health-related fitness in persons with SCI and (2) determine if the recommendations made by the Surgeon General for health-related physical fitness in the non-disabled are generalizeable to persons with SCI. Another long-term objective is to assess the influence of physical activity on secondary complications of SCI.
Comparison of Bone Mineral Density Between Men and Women with Chronic Obstructive Pulmonary Disease (COPD)
PI M. Covey, J. L. Larson, L. Alekel, D. Schwertz
Patients with chronic obstructive pulmonary disease (COPD) have risk factors for the development of osteoporosis including: heavy smoking history, corticosteroid use, sedentary life style. Few studies have examined the incidence of bone loss in these patients and no studies have compared bone mass in men and women with COPD. The purpose of this study is to examine the relationship of variables that potentially influence bone mass with current mineral density (BMD) in COPD patients. Additionally the BMD of the lumbar spine and proximal femur will be compared between men and women with COPD, and healthy men and healthy women. The sample will consist of 45 patients with COPD, and 45 healthy subjects. In order to control for the effects of smoking history vs disease state on BMD, the healthy group will be divided into those with a significant smoking history (>20 pack-years) versus those with minimal or no smoking history (<20 pack-years). Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA) at the following sites: PA lumbar spine, proximal femur, and whole body. Variables potentially influencing BMD will be measured: 1. calcium and ethanol intake as measured by the Block '98 Food Frequency Questionnaire, historical and current physical activity as measured by the Historical Leisure Time Activity Questionnaire and the Physical Activity Scale for the Elderly respectively, cumulative smoking history as measured by the number of pack-years, gonadal hormones as measured by serum testosterone and serum estradiol levels, corticosteroid use as measured by clinical questionnaire, body mass as measured by body weight and whole body DXA scan. Statistical analysis will include: 1. univariate linear regression with lumbar spine BMD and proximal femur BMD as dependent variables and smoking history, disease state, calcium intake, ethanol intake, physical activity, gonadal hormone levels, corticosteroid use, body mass as independent variables; and 2. analysis of variance with lumbar spine BMD and proximal femur BMD as dependent variables. Results of this study will provide improved understanding of the nature of bone loss in COPD patients.
Survivors in Motion: An Instrumentation Study
PI L. Finnegan, B. Riley
Two-thirds of the more than 270,000 Americans who are childhood cancer survivors will face at least one treatment-related late effect. Lifestyle choices in combination with late effects put this vulnerable population at risk for premature development and accelerated progression of diseases associated with aging, such as hypertension, diabetes, coronary artery disease, and osteoporosis. Engaging in regular moderate-intensity physical activity of at least 30 minutes on most days of the week may ameliorate some of these risks. This study is part of a series of investigations that will lead to the development and testing of a computer-tailored physical activity assessment and intervention system designed for young adult survivors of childhood cancer. An important first step in the development of this system is the validation of measures of physical activity determinants. Specifically, this study aims to evaluate the psychometric properties of four rating scales that measure important determinants of physical activity adoption (self-determination, self-efficacy, decisional balance, and health-related worries) in young adult survivors of childhood cancer.
In this descriptive, cross-sectional instrumentation study, 100 young adult cancer survivors will respond to a Web-based survey, which contains measures of self-determination, self-efficacy, decisional balance, health-related worries, physical activity stages of change, and background variables. Participants will be recruited through cancer survivor-related Web sites, newsgroups, listservs, live chat rooms, and long-term survivor clinics. The measures of self-determination, self-efficacy, decisional balance, and health-related worries will be subjected to Rasch analysis using the WINSTEPS software program. Three areas will be examined: 1) unidimensionality of constructs; 2) targeting item parameters to sample configurations on the latent constructs; and 3) analysis of rating scale structure. In addition, test-retest reliabilities will be assessed for these four measures. The results of this study will be used to refine the instruments for subsequent studies, in which a computer-tailored physical activity assessment and intervention system will be developed and tested.
A Pilot Study: Patterns of Fatigue, Physical Activity, Health Status, and Quality of Life in Stem Cell Transplant Patients
PI E. Hacker, C. Ferrans, K. van Besien, F. Ravandi
The stem cell transplant procedure and high-dose chemotherapy with or without total body irradiation has the potential to impact all aspects of a patient's life, particularly during the immediate post transplant period. Problems, such as fatigue and decreased physical activity, may result in long-term functional consequences eventually affecting the patient's ability to maintain or return to productive roles. The purpose of this pilot study is to examine the patterns of fatigue, physical activity, health status, and quality of life among stem cell transplant patients immediately following the stem cell transplant. A secondary purpose of this study is to determine the feasibility of using the Actiwatch-Score (wrist actigraphy with a subjective event marker) as a patient-tolerable means for obtaining fatigue and physical activity data. The specific aims of this study are to (a) to describe and measure changes in fatigue, physical activity, health status, and quality of life pre and post transplant; and, (b) to conduct a preliminary examination of the relationships between (a) fatigue and physical activity; (b) physical activity and health status; and, (c) health status and quality of life in stem cell transplant patients. Wilson and Cleary's Conceptual Model for Patient Outcomes will be used to guide the description of symptoms, functional ability, health status and overall quality of life. The model will also guide a preliminary examination of the relationship between these variables. It is anticipated that future studies will examine the causal relationships between the various types of patient outcomes and identify salient individual and environmental contributory factors. The main research variables include (a) fatigue; (b) physical activity; (c) health status; and, (d) quality of life. This study will employ a prospective, repeated measures design. The outpatient hematology/oncology clinics and the inpatient stem cell transplant units at the University of Illinois at Chicago Medical Center and University of Chicago Hospitals will serve as the setting. Convenience sampling will be used to accrue a target sample of 15 patients. Data will be collected before and after the stem cell transplant. Data collection will begin before the transplant (time 1 = prior to hospital admission for the stem cell transplant). Data will be collected over a three day period. Information from this time period will provide baseline data for fatigue, activity levels, health status and quality of life as well as the ability and willingness of patients to provide complete data using wrist actigraphy. The second data collection period will be 4-8 days post stem cell transplant (time 2). It is expected that this time period will coincide with the period of profound neutropenia and the impact of acute side effects from the intensive therapy. Data from this time period will provide information regarding types of problems experienced following the intensive therapy and stem cell rescue as well as the ability and willingness of patients to provide complete data using wrist actigraphy when experiencing the full impact of the intensive therapy. Fatigue intensity will be measured using a 1 to 10 rating scale via the subjective event on the wrist actigraph device. Physical activity will be measured via wrist actigraphy over a 3-day period pre and post transplant. Health status will be measured by the European Organization for Research and Training, Quality of Life Questionnaire - Core 30 and quality of life will be measured by the Quality of Life Index. The findings from this pilot study will be used to design a larger study using similar subjects from multiple institutions. In addition, the pilot study findings will be used to refine the methodology associated with using the Actiwatch-Score to measure fatigue and physical activity.
Investigation of New CVD Risk Markers in Post-Menopausal Women with Coronary Artery Calcium
PI J. A. Hoff, G. T. Kondos, M. L. Daviglus, M. Piano, J. Zerwic
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality among women in the U.S. It accounts for nearly 500,000 deaths annually with coronary artery disease (CAD) accounting for more than half of the deaths. Conventional CAD risk factors are cigarette smoking, dyslipidemias, hypertension, diabetes, and obesity. Oral contraceptive use, menopause, and post-menopausal hormone replacement therapy status have been shown to be unique CAD risk factors for women. CAD primary prevention efforts for both men and women focus on the identification and management of CAD risk factors, yet studies have shown that risk factors predict less than 50% of all cardiovascular events and 50% of all myocardial infarctions occur in individuals with normal plasma lipid levels. In an effort to better identify and stratify risk of atherosclerotic events in healthy populations several new markers of CAD risk have been proposed for use in screening they are: lipoprotein (a) [Lp(a)], homocysteine (tHcy), C-reactive protein (CRP), particle size and various concentrations of low density lipoproteins (LDL) and high density lipoproteins (HDL). This proposal seeks to conduct a pilot study that will explore the prevalence of new markers of CAD risk and clinically measured CAD risk factors among a cohort of self-referred, post-menopausal women who have subclinical CAD as measured by electron beam tomography (EBT) and self-report the absence of conventional CAD risk factors. EBT allows for noninvasive detection and quantification of coronary artery calcium, a subclinical marker for CAD. The results of this pilot study will serve as preliminary data for a future NIH study in post-menopausal women that will investigate the association of new CVD markers and subclinical CAD as measured by EBT. In addition, longitudinal follow-up of a larger cohort will enable the determination of those CAD factors and CVD markers that are most predictive of CAD risk in post-menopausal women. Considering that nearly 50 million American women are now more than 50 years of age, there is not a more important health issue than the primary prevention of CVD.
Home Telehealth Monitoring of Elderly Cardiac Surgery Patients: A Pilot Study
PI R. Kleinpell, M. Piano, B. Avitall
A growing number of elderly patients are receiving coronary artery bypass graft (CABG) surgery, the most frequently performed major surgery and one of the most costly single treatments for coronary heart disease. Prevention of complications, including hospital readmissions are important, yet interventions to improve elders' outcomes after CABG are lacking.
Purpose: The purpose of this pilot study is to examine the feasibility of an intensive care unit (ICU) based early discharge planning, home telehealth monitoring, and telephone intervention for elderly (age > 65) cardiac surgery patients. The specific aims of this pilot study are to:
Aim 1. Determine the feasibility of the discharge planning and telephone intervention for cardiac elderly (DICE) patients in terms of:
1: format and structure of the hospital based discharge planning intervention
2: use and duration of use of home based telehealth monitoring
3: format and structure of the home-based telephone follow up
Aim 2. Test the feasibility of the DICE intervention in measuring post hospitalization outcomes in terms of :
1: monitoring postoperative recovery
2: detection of postoperative complications
Subjects: 10 patients at the University of Illinois Hospital meeting inclusion criteria will be approached by the PI for study participation in the hospital after cardiac surgery (inclusion criteria: age > 65; post CABG; written informed consent; physician approval; classification as “high risk” for cardiac complications [documented history of congestive heart failure; New York Heart Association (NYHA) functional classification III or IV, echocardiographic evidence of low ejection fraction (< 40%), or history of atrial fibrillation] or “high risk” for postdischarge complications [postoperative (PO) myocardial infarction (MI), arrhythmias requiring treatment, reoperation, cardiac arrest, wound dehiscience, positive wound culture, prolonged PO ICU stay > 2 days, prolonged PO mechanical (MV) ventilation > 2 days, or does not meet postoperative CABG clinical pathway discharge goals by postoperative day (POD) 5; able to read and speak English; possession of a home telephone; possession of a mailing address.
Design: Descriptive, non-experimental design
Intervention: DICE consists of 1) ICU based discharge screening, 2) reinforcement of the discharge plan, 3) home based telehealth monitoring, and 4) post-discharge telephone follow up at 1day, 3 days, and weekly for 4 weeks. Modified DICE consists of 1) ICU based discharge screening, 2) reinforcement of the discharge plan, and 3) post-discharge telephone follow up at 1day, 3 days, and weekly for 4 weeks.
Implications: The proposed study represents continuation of the PI’s research trajectory in studying outcomes for the critically ill elderly. This feasibility pilot study is being conducted in order to refine the protocol to then be proposed in an RO1 resubmission to the National Institute of Nursing Research (NINR).
Reducing Cardiovascular Risk in Adults with Serious Mental Illness: Walking Adherence
PI J. McDevitt, J. Wilbur, J. Briller, J. Kogan, M. Schneiderhan, M. Snyder
The purpose of this quasi-experimental study is to determine adherence to a group-based, moderate-intensity walking program to improve cardiovascular fitness in adults with serious and persistent mental illness (SPMI) using the Physical Activity Behavior Framework to guide the study. Persons with SPMI have multiple risks for cardiovascular disease, including obesity, sedentary lifestyle, and smoking. Even if their psychiatric treatment is effective, they remain at risk for premature disability and death due to cardiovascular disease. Although regular aerobic exercise is known to reduce cardiovascular risk, little is known about exercise adherence in psychotic illness. The critical elements for effective programs to develop fitness in persons with SPMI have not been determined, nor are health outcomes of such programs known.
Fifteen volunteers aged 20-50 who are in psychiatric rehabilitation will participate in a 12-week walking program meeting 3 times a week for one hour. Developed specifically for persons living with SPMI, the program will combine supervised moderate intensity walking with emotional support and health information tailored to accommodate the cognitive and motivational deficits that often accompany mental illness. The program will be coached by a psychiatric rehabilitation caseworker cross-trained to model, educate, and support participants as they progress according to individualized exercise prescriptions for frequency, intensity, and duration established by preprogram aerobic fitness testing.
Baseline measures will include background factors of demographics, psychiatric diagnosis, medications, and cardiovascular risk (blood pressure, body
composition, lipoproteins, and V02max) and personal factors of exercise motivation (Self-Efficacy for Overcoming Barriers to Exercise Scale, Decisional Balance Scale, Self-Rated Change in Exercise Behavior Scale), knowledge (Physical Activity and Heart Disease IQ), feelings (Profile of Mood States), and psychosocial functioning (caseworker-rated Multnomah Community Ability Scale for Mental Health Clients). Outcome measures will include the proposed mediating factors of exercise motivation and knowledge (repeating measures used at baseline), adherence to walking (exercise logs, heart rate monitor data for each exercise session), cardiovascular health (blood pressure and body composition), and mental health (feelings and psychosocial functioning, repeating measures used at baseline). Data analysis will include descriptive statistics for adherence; exploratory regression modeling to determine the influence of background factors and the personal/mediating factors of exercise motivation and knowledge on adherence to walking; and correlations, t-tests, and analysis of variance to compare change in exercise motivation and knowledge and in cardiovascular health and mental health from baseline to after a moderate intensity walking program.
If adults with SPMI can adhere to a low-cost, safe program for moderate intensity exercise that can easily be integrated into their psychosocial rehabilitation, it will provide a way to reduce cardiovascular risk and improve health in this vulnerable population.
The Effects of Ovariectomy on Alcohol Consumption and Dilated Cardiomyopathy in Female Rats: A Pilot Study
PI M. Piano
The purpose of this pilot study is to determine the effects of ovariectomy (OVX) and OVX + estrogen (EST) replacement (EST, 17b estradiol) on the daily consumption of ethanol, the pattern of ethanol consumption and blood ethanol levels in female rats over a four month period. In addition, it will be determined if this short duration of ethanol consumption is associated with changes in ventricular structure and function. These preliminary data will be used to support the re-submission of a larger NIH proposal designed to examine potential neurohormonal mechanisms involved in the pathogenesis of alcoholic cardiomyopathy (ACM) in OVX and OVX + EST replacement in ethanol-fed female rats. Virus-free sexually mature female Fisher 344 rats will be used in all ethanol/control liquid diet experiments. Animals will be divided into the following groups: OVX Control, OVX +EST control, sham operated control, OVX ethanol-fed, OVX +EST ethanol-fed, and sham operated ethanol-fed. OVX rats receiving the EST replacement therapy will be implanted with a subcutaneous 90-day slow release hormone pellet containing 1.5 mg of 17b-estradiol. All animals will receive the nutritiously complete Lieber DeCarli diet daily for 4 months. Echocardiographs and blood pressure will be measured at 1 month intervals for the duration of the study.
It is well established that there are gender disparities in the occurrence and manifestations of cardiovascular disease, which may be related to the presence or absence of specific sex hormones. In both men and women, long term heavy alcohol use is one on the most prevalent toxic causes of a dilated cardiomyopathy. Some studies indicate female gender may be a risk factor for the development of ACM, whereas other studies have reported the female myocardium was resistant to the effects of alcohol. To date there are few studies which have examined sex-differences in the susceptibility, progression or clinical characteristics of ACM in women and no studies have considered the effects of EST.
Diabetes, Exercise, and Postprandial Oxidative Stress
PI L. Quinn, P. Bowen, E. Emeson, I. Brodsky, J. Rimmer
In the US, type 2 diabetes affects 90% of the 15.6 million individuals with diabetes (DM) and is associated with a two to fourfold increase in cardiovascular disease (CVD). Although postprandial oxidative stress, CHO and lipid metabolism have been implicated in the pathogenesis of CVD, the ability of acute aerobic exercise to modify these variables has not been explored in type 2 DM. This study will compare the effects of an acute bout of aerobic exercise (45 minutes of treadmill walking at 60% V02 Max) in a group of physically untrained subjects with younger-onset type 2 DM and control subjects on: (1) parameters of postprandial CHO and lipid metabolism (glucose, insulin, C-peptides, triglycerides), following 3 meals; (2) parameters of postprandial oxidative stress (total MDA, total hydroperoxides) and LDL susceptibility to oxidation, following 3 meals. In addition, the relationship between baseline insulin sensitivity, antioxidant status, V02 Max and postprandial changes in parameters of oxidative stress CHO and lipid metabolism will be explored. The study will include 11 subjects with type 2 diabetes (age 18-40 years) with duration of diabetes (< 7 years) who will participate in a nonexercise and exercise protocols, performed in random order. On day 1 of the exercise protocol, a euglycemic, hyperinsulinemic glucose clamp will be performed. On day 2 at 0800 hours, baseline parameters of oxidative stress, LDL susceptibility to oxidation, CHO and lipid metabolism will be obtained prior to an acute bout of aerobic exercise and periodically throughout the postexercise period, during which three meals will be consumed. The diet will follow American Heart Association (AHA) National Cholesterol Education Program (NCEP1) guidelines with 30% fat as energy, with 10:10:10 % from saturated, monounsaturated and polyunsaturated fat, respectively with 1/3 of energy requirements to be consumed at each meal. On nonexercise experimental day, the same protocol will be followed without the acute exercise bout. The use of aerobic exercise to influence CHO and lipid represents a new approach to using aerobic exercise as a treatment for type 2 diabetes with a long-term goal of impacting complications, such as CVD.
Coronary Artery Calcium and Cholesterol Profiles in HIV Infected Men on Highly Active Antiretroviral Therapy
PI P. Robinson
Treatment with highly active antiretroviral therapy (HAART) successfully suppresses viral replication, restores or stabilizes immune function, and can improve quality of life in individuals infected with HIV. The advent of HAART has greatly reduced HIV-related morbidity and mortality. However, treatment with HAART, especially regimens containing protease inhibitors, has been associated with development of metabolic abnormalities collectively known as lipodystrophy syndrome. This syndrome includes: dislipidemia, insulin resistance, and fat redistribution. These metabolic abnormalities are established risk factors for the development of atherosclerotic coronary artery disease (CAD). Indeed, case reports indicate that individuals treated with HAART have developed premature CAD. However, it is unclear whether HAART treatment presents an independent risk factor for atherosclerotic vascular disease. Thus, investigations that quantify the contribution of HAART to atherogensis are needed. The purpose of this study is to explore the differences in quantifiable CAD risk factors between HIV-infected individuals treated with HAART and HIV-negative controls. A cross-sectional descriptive design will be used where data from HIV-infected men being treated with HAART will be compared with HIV-negative either age-matched control or normative data. Specifically, differences in coronary artery calcium (CAC) scores measured by electron beam tomography (EBT) will be determined as calcium accumulates at the base of an atherosclerotic plaque and is a very important marker of disease presence. Additionally, blood glucose and cholesterol levels will be measured and compared. Seventy-five (N=75) HIV-infected men on HAART regimes will be recruited.
Symptom Clusters in Adults with Myocardial Infarction
PI C. Ryan, J. Zerwic, D. Moser, A. Rosenfeld, H. DeVon, K. Milner, S. Wung, R. Horne
Many health-related texts and patient teaching materials related to acute myocardial infarction (AMI) portray the symptom experience related to AMI as unidimensional, focusing on chest pain as the primary symptom of AMI. Data, however, suggest that, during AMI, persons experience a constellation of symptoms and that chest pain does not occur in isolation. Research on symptoms has indicated that, when people identify a single symptom of illness, they seek to validate that this symptom represents illness by identifying other symptoms that may accompany it. Previous studies of the AMI symptom experience have been limited related to the methods used to collect and analyze the data. Traditionally, these studies use sequential methods that force individuals to consider their symptoms individually and do not allow research participants to report symptoms as clusters or groups. The purpose of this study is to identify and describe the cluster(s) of symptoms that is/are experienced with AMI and to compare and contrast the symptom cluster(s) that various demographic groups experience. Specifically, recent research has demonstrated that women, older persons, and minorities may experience different symptoms related to AMI than those of the traditional model, which has been built upon the symptoms of white males. This study will include a secondary analysis of data that have been previously collected in face-to-face interviews of persons who have recently experienced AMI. De-identified data will be obtained from researchers across the United States who study AMI symptoms. Data will be combined into one large database. Statistical analysis will include: 1. Cluster analysis techniques to identify if indeed there are clusters of symptoms that occur during AMI in the general population and to identify clusters of symptoms that are related to AMI in specific demographic subgroups (gender-specific, age-specific, and race-specific).
Measurement of Lifestyle Physical Activity in Arthritis
PI P. Semanik, J. Wilbur, R. Chang, M. Minor, M. Carr
The purpose of this study is to attain a self-report instrument of lifestyle physical activity that is relevant to the physical activity patterns, accurate for estimating the energy expenditure, and reflective of the health-related physiological outcomes of physical activity in older women with rheumatoid arthritis (RA). The specific aims are to: (1) determine the two-week test-retest reliability scores for the seven-day recall Yale Physical Activity Survey (YPAS) summary index scores (Total Time Index, Energy Expenditure Index, Activity Dimensions Index) as a measure of physical activity behavior in older women with RA; (2) determine the relationship of the YPAS summary index scores to concurrently measured motion counts (accelerometer-estimated movement during the performance of lifestyle physical activities) and self-reported physical activity (7-day daily physical activity log: time and energy expenditure summaries); (3) describe the relationship of the YPAS summary index scores to physiological indicators known to be related to physical activity levels (i.e., blood pressure, body composition, and cardiorespiratory fitness); (4) describe the relationship of the YPAS summary index scores to the participants’ functional and pain statuses as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The study will include 22 women aged > 60 years, diagnosed with RA, able to walk household distances, without lower extremity problems in addition to RA, and with no signs or symptoms of cardiovascular disease. Women will be recruited from arthritis outpatient clinics. The YPAS will be administered at baseline, 14, and 21 days and the WOMAC at baseline. Physiological indicators will be taken at baseline and day 14. Concurrent measures (accelerometer, daily physical activity log) will be worn and recorded by women during daily activity for seven days (days 14 to 21). Analyses include descriptive statistics, intraclass correlation coefficients, Pearson product moment correlation coefficients, and analysis of variance. The identification of relevant, sensitive, reliable, and valid self-report measures of lifestyle physical activity in older women with arthritis is a necessary precursor to the development and study of physical activity interventions.
Cognitive Testing of the Computerized PAINReportIt Program in Adult African Americans, Hispanic Americans, and European Americans with Sickle Cell Disease or Cancer
PI Diana Wilkie, C. Ferrans, R. Molokie, D. Mehta, M. Suarez
The long-term goal of the study is to relieve pain related to sickle cell disease and cancer by using computers to support clinical care processes related to clinicians’ assessment of pain. Our recent findings from studies with the general public and cancer patients show that people are able to use computers to report their pain. The previous studies, however, were conducted with a largely Caucasian sample, and it is unclear if the instrument items and instructions are appropriate for African American and Hispanic minority populations suffering from either sickle cell disease or cancer. Successful use of the computerized pain assessment tool could lead to improved pain relief for the 1.3 million people diagnosed annually with cancer and for the 72,000 Americans living with sickle cell disease, people mainly of African American, Mediterranean, or Latin American descent. To address this instrumentation problem, we propose a pilot study in which we will conduct 50 cognitive (think-aloud) interviews with patients as they complete PAINReportIt to refine and validate the items that measure the multiple dimensions of sickle cell pain or cancer pain. The specific aim is to determine the meanings attributed to the PAINReportIt items by 25 patients diagnosed with sickle cell disease and 25 patients diagnosed with cancer, all of whom are currently experiencing pain. Based on study findings, we will modify the wording and presentation of the PAINReportIt items and instruction screens for use in our current or pending NIH-funded studies of cancer patients (2 RO1 CA081918-06; 1RO1 CA81918-11-1A; 1RO1 NR009092-01-1A) and people with sickle cell disease (1RO1 HL078536-01A).
The Effects of a Wellness Intervention on Outcomes in Persons with Dementia
S. C. Burgener, Y. Yang
To date, systematic studies are lacking that demonstrate the effects of interventions designed to improve the general quality of life, including cognitive and physical functioning, in persons with dementia (PWD). This study purpose, then, is to test the effectiveness of a wellness intervention on outcomes in PWD, with the specific purpose of this proposal being to test the effectiveness of a 40-week, versus 20-week intervention. The tripartite intervention targets the overall functioning of PWD including: 1) Taiji exercises focusing on strength, balance, and fall prevention; 2) Cognitive-behavioral therapies addressing memory, social functioning, and mental and emotional well-being; and 3) Support group participation addressing self concept, social isolation, and self-esteem. PWD willing to commit to at least a 20-week intervention were randomized into either the treatment or comparison (wait) group, with an anticipated >90% of the treatment group desiring to continue for a total of 40 weeks. Criteria for participation of the PWD include: 1) a confirmed, recent (within one year) diagnosis of irreversible dementia; and 2) a score < 2.0 on the Clinical Dementia Rating Scale indicating an early to early-middle disease stage. Outcome variables for the PWD include: muscle strength, balance, fear of falling and actual falls, cognitive functioning, self-esteem, sleep quality, physical illness, activity participation, and depression. Caregiver outcomes are also measured including role stress and quality of the relationship with the PWD. Planned analyses include between group differences for the treatment effect, within group differences for length of treatment (20 vs. 40 weeks), and between group differences for length of treatment.
A Culture-Specific Intervention for Breast Cancer Screening in Korean American Women
E. E. Lee, A. Miller, L. Fogg
The mammography screening rate for Korean American (KA) women is much lower than for other ethnic groups even though the age-adjusted breast cancer incidence rate is the highest among all types of cancers in KA women. As the number of Koreans in the United States increases, and as the population lives longer, the number of KA women at high risk for breast cancer is also likely to increase. The purpose of this proposed pilot study is to test the feasibility of a culture-specific breast cancer–screening intervention for KA immigrant women . This proposed Intervention will use a Korean-language videotape that focuses on (1) improving knowledge about breast cancer and cancer screening, (2) addressing common cultural beliefs that are barriers to cancer screening, (3) fostering family support/encouragement for screening, (4) improving women’s skills for obtaining screening as well as for examining their own breasts, and (5) providing recommendations for breast cancer screening. This pilot intervention study is culture specific in terms of (1) the content of the tape and (2) the intervention-delivery method. This study is guided by the Anderson & Aday’s Behavioral model, the Health Belief Model, and the T ranstheoretical model. To achieve the specific aims, the proposed project will be conducted in 4 phases: (1) develop a script for the videotape based on existing educational materials , literature review, and findings from the investigators’ previous work ; (2) evaluate content validity of the script in consultation with experts; (3) make the videotape for the intervention; and (4) deliver the intervention to KA women aged 40 and older (N = 15) who are recruited from a church. Results of this feasibility study will be used for a culture-specific breast cancer screening intervention study for KA women . The proposal will be submitted to the National Institute of Nursing (NINR) for a competitive R01 grant in February 2006 .
The results of this proposed study will be used for a larger scale intervention study that is going to be proposed to the NIH/NINR in year 2005 or 2006. The intervention is eventually expected to contribute to decrease the breast cancer screening disparities among KA women that eventually lead to decrease in breast cancer related mortality and morbidity for them.
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