Research Base
The research base of the Center consists of the externally funded, peer-reviewed projects that formed the basis of the original grant proposal. Five of these studies, along with their significance and connection to the health trajectory theme, are described in some detail below.
A Fall Prevention Program for High-Risk Elderly Women
Funding: NINR/Office of Women's Health
PI: Jean F. Wyman
The long-term goal of this project is to develop cost-effective, community-based strategies to prevent falls in high-risk elderly women. This is a randomized, controlled, single-blinded trial with two groups. Participants in the fall prevention program receive a 12-week home-based intervention (moderate intensity exercise program, tailored risk reduction education) that involves alternating biweekly visits and telephone calls, followed by a tapered 16-week exercise adherence intervention using an automated, voice response interactive telephone system. Control group participants receive a program of health education. Measures of fall rates, postural competence, functional status, mood, health related quality of life and fear of falling, fall-related injuries, and health service utilization and costs are gathered at baseline and at several points over a two-year period.
This study has a high level of significance for the quality of life of older individuals. Falls, falls-related morbidity and mortality and associated costs, and the larger impact of falls and the fear of falling on older adults' ability and willingness to function in the world are issues of great concern to clinicians, social gerontologists, and policy makers alike. The study's use of the Transtheoretical Model as its conceptual framework lends further significance to the study. This represents an effort to demonstrate an intervention approach that is tailored to an individual's stage of readiness to engage in positive health behaviors. The study also employs a two-year timeframe, long by the standards of most intervention research, which will permit the examination of the robustness of an innovative adherence strategy that relies on computerized phone technology that can be readily used in other situations.
This study represents an excellent example of the kind of research that is supported by and contributes to the scientific theme of our proposed Center. The focus on an acute health challenge that can potentially result in a downward health trajectory leading to institutionalization requires new prevention strategies. The intervention is sensitive to the individual differences among its participants as well as to the high degree of covariation likely to be produced by the women's co-existing (and developing) health and socioeconomic challenges. While the intervention acts on developing health behaviors (exercise), it recognizes the social and environmental constraints that high-risk elderly women face and accommodates to these by using technology (the phone) as a means of providing on-going encouragement for maintaining their healthy behaviors. By looking at participants over a two-year period, the study enables the investigator to examine the health outcomes' trajectories of participants and to discern not only an outcome at a single point in time but the pathways participants travel over time to arrive at those outcome points. If the intervention is successful, then it will be redesigned for broader dissemination and evaluation at a population level.
The Impact of Fiber Fermentation on Fecal Incontinence
Funding: NINR
PI: Dr. Donna Z. Bliss
Fecal incontinence is a chronic problem with debilitating effects on health and well-being. Symptom management is essential to maintain the dignity, self-esteem, and health of the individual, ease the burden of caregivers, and prevent nursing home admission. The study aims to address a major gap in the clinical management of fecal incontinence, a lack of research on interventions to firm stool consistency in fecal incontinence. The study has long-range promise for offering recommendations about the use of soluble dietary fiber to manage fecal incontinence. This is a randomized, controlled, single-blinded study involving a placebo control group and experimental group receiving three kinds of dietary fiber supplements. Outcome measures include incontinent episodes, stool consistency, and condition-specific quality of life.
Fecal incontinence is a problem that, while not as common as urinary incontinence, is prevalent and does have very serious consequences for the lives of those affected. It is a much more serious deterrent to social participation and interaction than is urinary incontinence, and therefore more powerfully prevents those affected from enjoying the well-documented benefits of social interaction. Its effects on relationships are likewise severe. This study's use of a dietary supplement is biochemically-based in that it builds on a link between the fermentation of dietary fiber in the gut and intestine and the consistency of stool (with leakage affected by looseness or firmness). In this way, the study can be considered translational: it applies basic science principles to the solution of an important clinical (and social) problem.
The study relates well to the scientific theme of our Center. Its principal focus is on a chronic health challenge, one whose trajectory can vary widely, over time, depending on the effectiveness of interventions to address it. Within the context of the Center's model, the study intervention is aimed at a biological determinant of health. Of all of the studies that form the scientific base of the center, this is the most specifically biological in nature. Yet the study's dependent variables, in keeping with the Center's theme, include quality of life outcome measures. The longer-term agenda of this work also relates well to the theme of the Center. Participants in this study are very closely monitored and shepherded to assure the accuracy of information about dietary intake. Once the efficacy of the fiber supplement is established, a next step will be to develop and test a way to make this intervention available in a way that participants adhere to the regimen with far less supervision. Thus next steps will involve other determinants of health, including the development and reinforcement of healthy behaviors (following the diet on one's own) and perhaps the use of environmental reinforcers, such as the automated telephone system used in Dr. Wyman's current study. In addition, a broader conceptualization of the experiment itself developed, one that includes family interactions among the determinants.
Predictors of a Successful Response to Exercise Training
Funding: AHA
PI: Dr. Diane Treat-Jacobson
This study is concerned with testing a non-invasive treatment modality for a condition - peripheral arterial disease (PAD) - that affects over 10 million Americans, a number sure to grow as the number of older Americans grows. Broadly speaking, this study is linked to the fields of cardiac rehabilitation and, more generally, gerontology. The concerns of the study relate to concerns about treating a progressive condition - to treat symptoms and retard progression - but also about quality of life, since PAD can, over time, restrict mobility and, therefore, social interaction. Because the study is so heavily dependent on patient participation and adherence to the study protocol, it is also linked to inquiry on self-efficacy and self-directed care.
The objective of this study of persons with PAD is to determine the efficacy of a supervised program of treadmill exercise training and arm ergometry, alone or in combination compared to persons in usual care. It also looks at the effect of additional unsupervised exercise on change in exercise capacity and to evaluate the durability of exercise. Participants are randomized into one of three training groups or a control group. Subjects in all training groups perform supervised exercise three times per week for 12 weeks in 70 minute sessions. Outcome measures are assessed at 12 and 24 weeks after baseline. The study examines functional and physiologic outcomes as well as participants' more subjective assessments of both the program and its effects on them.
This study is a preliminary examination of an intervention designed to affect two important and related health trajectories. One trajectory is disease-related - the progression of PAD. The other trajectory is more related to the psychosocial challenges presented to older people as they age and develop chronic conditions and the way in which their own inner resources can be mustered to meet these challenges. Thus, this study is focusing not only on producing a health behavior change (exercise) that is a determinant of a health outcome but it is also concerned with the more individual aspects of exercise that promote a positive predisposition to continue the behavior beyond the prescribed intervention period. While the intervention is based in a physiological model, it is, therefore, also grounded in a psychosocial one as well.
Impact of Mindfulness-Based Stress Reduction on Symptom Management in Solid Organ Transplant Recipients
Funding: NINR
Dr. Cynthia Gross
This study ties into a larger framework of complementary and alternative medicine (CAM) research. CAM represents an opportunity at two levels. Research on CAM provides a way to explore the management of conditions using methods that are less invasive and that encourage the incorporation of the person's mind, body, and spirit into the management method. This work also provides yet another way to make health care more patient-centered and patient-directed. The demonstration of CAM strategies that work with or in place of more traditional western medical modalities and treatments offers patients real choices.
This study explores the use of meditation and yoga as mind-body-based complementary therapies to improve solid organ transplant recipients' health-related quality of life. The overall goals of the study are to assess whether transplant recipients who consistently practice meditation and yoga experience fewer symptoms of anxiety, depression and sleep disturbance, utilize fewer medications to manage symptoms, and report improved health-related quality of life.
This study fits very well within the Center's scientific theme. This particular study, and the science behind it, focuses on the individual as an important determinant of a health outcome within a chronic illness trajectory newly altered by an organ transplantation. The intervention works in concert with other therapies, so other determinants (e.g, the biologic and the social environment) are also at work in the model.
Comprehensive Support for Alzheimer's Disease Caregivers
Funding: NIA
PI: Dr. Joseph E. Gaugler
Family care for Alzheimer's patients has received significant attention in the gerontological literature. Considerable research has demonstrated who caregivers are, what caregivers do, and the potential emotional, psychological, physical, social, and financial burdens caregivers experience. However, psychosociat interventions designed to alleviate negative caregiving outcomes generally report mixed results. One particular intervention that has proved successful in reducing caregiver depression and delaying care recipient institutionalization is the Enhanced Counseling and Support Intervention (ECS) implemented by Mittelman and her associates at the New York University Alzheimer's Disease Research Center (NYU-ADRC; see Mittelman et al., 1993; 1995). While the ECS was one of the few psychosocial interventions that have reported positive results, findings were limited to one experimental site and spouses of Alzheimer's patients. The proposed analysis will expand on prior research by: 1) testing the benefits of the ECS for Alzheimer's caregivers at a non-urban experimental site, the University of Kentucky Alzheimer's Disease Research Center (UK-ADRC); and 2) expanding the scope of the ECS by focusing on adult child Alzheimer's caregivers and comparing the benefits of the ECS intervention at both the UK-ADRC and NYU-ADRC sites. This 5-year study will use a randomized experimental design and will include 440 adult child caregivers across the two experimental sites (220 adult child caregivers at UK-ADRC; 220 adult child caregivers at NYU-ADRC). The experimental design (which will include the ECS treatment condition and a usual contact control group), up to 5-years of data collection, and a large sample size will allow for more valid and generalizable results than other psychosocial interventions. Moreover, the prospective longitudinal design with assessments beginning prior to enrollment, every 4 months during the first year of the intervention, and every 6 months thereafter will allow for use of sophisticated longitudinal analyses (i.e., growth curve models) to determine the effectiveness of the ECS. The proposed evaluation will provide detailed information on the potential of the ECS to serve as a model intervention for various family caregivers of Alzheimer's patients in diverse geographic contexts.
Prime Time: Health Promotion for Multiple Risk Behaviors
Funding: NINR
PI: Dr. Renee E. Sieving
Prime Time: Health Promotion for Multiple Risk Behaviors is a 5-year intervention research study (2006-2011) with an overall goal to design, implement and evaluate a multi-component intervention among adolescent girls at high risk for early pregnancy that reduces multiple precursors of teen pregnancy including sexual risk taking, violence involvement, and school disconnection. Prime Time targets 13-17 year old girls attending school and community clinics in Minneapolis/St Paul who meet specified inclusion criteria. Using an experimental design, half of study participants are randomly assigned to the intervention condition; half are assigned to the control condition. Intervention participants will be involved with the Prime Time intervention for an 18-month period, while control participants will continue to receive usual clinic services. Self-report data will be collected (via A-CASI surveys) from all study participants at study baseline and at 6, 12, 18, 24, and 30 months following study enrollment. To address core risk and protective factors related to sexual risk behaviors, violence involvement, and school disconnection, the Prime Time intervention employs an innovative combination of previously-tested approaches including one-on-one case management, peer education (Just In Time) and service learning (It's Our Time) experiences. This multi-component intervention was developed and field-tested in the Prime Time pilot study. Using multi-wave data, we evaluate intervention impacts on participants' sexual risk taking and contraceptive behaviors; school connectedness, school misbehavior and school performance; violence involvement and peer-related aggression. We also test the extent to which intervention effects on outcome behaviors are mediated by hypothesized risk and protective factors targeted for change by the Prime Time intervention. If the intervention demonstrates success in preventing risk behaviors, we will actively engage in dissemination efforts to affect best practices in primary care clinics serving adolescent girls.
Anxiety Self-Management for Patients Receiving Mechanical Ventilatory Support
Funding: NINR
PI: Dr. Linda Chlan
The primary aim of this proposed study is to determine if music can reduce ventilated patients' anxiety and stress. Despite being a life-saving intervention, receiving mechanical ventilatory support can be physiologically and psychologically distressful for patients. In order to promote tolerance of intubation and mechanical ventilation, a variety of intravenous sedative agents are frequently administered to these critically ill patients. Goals of sedative treatment include prevention/treatment of anxiety, promotion of patient-ventilator synchrony, and modulation of the physiological response to stress. Clinical practice guidelines articulated by the Society of Critical Care Medicine (SCCM) for the use of sedatives and analgesics in critically ill adults recommend the use of non-pharmacologic strategies such as titrating environmental stimulation, relaxation, music therapy, and massage for these patients. However, non-pharmacologic approaches are frequently underutilized in mechanically ventilated patients because they lack rigorous evaluation in large-scale clinical trials that document their benefit.
One non-pharmacologic intervention strategy that has been examined in small-scale studies is music. Music is a safe, inexpensive adjunct free of adverse side effects that has shown promise in limited, single intervention trials for reducing anxiety in ventilated patients. Music is an ideal non-pharmacologic intervention in that it is a familiar, comforting stimulus for many persons. This proposed study will determine if music can reduce anxiety and stress if ventilated patients are provided the opportunity to listen to music whenever desired and for as long as desired. We also propose to explore any attendant influences on length of ventilatory support, length of ICU stay, and stress as measured by urinary cortisol. Data will be analyzed via descriptive statistics and generalized estimating equations. The proposed project extends this PI's preliminary research findings documenting the immediate benefits of music intervention for reducing anxiety and promoting relaxation to testing the effects of music over repeated interventions as directed by the patient in order to influence ICU patient outcomes.
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