It is recognized that older African Americans with diabetes experience substantially worse progress and outcomes to care. To address this problem, the goal of the proposed Intervention Development Study (IDS) is to develop and evaluate an age-appropriate intervention designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment and diabetes-specific knowledge among African Americans over the age of 65 years.
Specific aims of the project are: 1) to develop an intervention to prevent functional decline by improving self-efficacy and self-management skills among older African Americans with diabetes; 2) to test the effect of this empowerment intervention that focuses on increasing self-efficacy, knowledge about diabetes care, and self-care skills among older African Americans with diabetes on glycemic control, lipid levels, blood pressure, weight, diabetes-related symptoms, quality of life and costs of care; 3) to describe the relationship between improving patient knowledge of needed diabetes care on receipt of indicators of good process of care such as dilated eye examinations, foot examinations, glycosylated hemoglobin and lipid testing; and 4) to describe the relationship between any intervention-driven changes in physiologic health (glycemic control, weight and symptoms) and changes in multidimensional functional status. The IDS will have two phases. During Phase I, we will use focus groups to develop a self-care intervention that incorporates age-appropriate elements of a theoretically-based existing educational curriculum that has been shown to be effective among younger African Americans with diabetes. We will present the content of the existing curriculum to African Americans with diabetes who are 65 years and older, and to providers who care for older persons with diabetes. The study team will evaluate the feasibility and acceptability of specific elements of the proposed intervention. Additionally, participants will have an opportunity to indicate the areas of self-care that they feel they need the most help with. During Phase II, the study team will use a randomized clinical trial (RCT) to implement and evaluate the effectiveness of the intervention in the target population on: 1) biophysiological markers of diabetes-related health such as glycosylated hemoglobin, blood pressure, and fasting lipid levels; 2) intervening variables such as self-efficacy, diabetes-specific knowledge, and self-care behaviors; and 3) psychosocial outcome variables such as quality of life, including multi-dimensional functional status and depression. This phase of the research will begin with a run-in period where 10 patients will be randomized from each site. The results of the run-in will be used to further refine the intervention before we implement the full RCT. By developing and implementing the intervention, we set out to identify a low cost means by which to improve the health and quality of life of older African Americans with diabetes. Additionally, and most importantly, the IDS will provide the needed data on effect size for functional status outcomes which will be used to design a future multi-center trial of the intervention.
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