Abstract
Despite the importance of asymptomatic coronary artery disease (CAD) in individuals with type 2 diabetes mellitus (T2DM), multidisciplinary interventions have not yet been developed for this population with unique self-management needs. The purpose of the proposed pilot study is to develop and evaluate the implementation of a multidisciplinary intervention for asymptomatic myocardial ischemia (MIAMI) in the high-risk population with T2DM. A previously tested cognitive-behavioral intervention of DM education (4 sessions), coping skills training (CST) (4 sessions), and T2DM care, developed by the investigators to improve self-management of T2DM and CAD risk factors and quality of life (QOL) will be extended to include two innovative, additional aspects - individualized psychological support and physical activity. Specific aims of the project are to:
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Determine the feasibility of instituting the proposed MIAMI.
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Pilot test study procedures and estimate effect size.
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Determine the preliminary effectiveness of the MIAMI on: a) illness-related (self-management of DM and CAD); b) individual (depressive symptoms, anxiety, autonomous motivation, perceived competence, and QOL); and c) health care system factors (autonomy support) at 3 and 6 months.
Eight to ten subjects with T2DM currently participating in a screening trial for asymptomatic CAD will be randomized to receive either the MIAMI with a standard physical activity intervention (control group) or the MIAMI with a more intensively supported physical activity intervention (experimental group). They will continue to receive medical care by their primary care providers, but medical therapy will be maximized under medical direction of the investigators.
Feedback to care providers on self-management of DM (HbA1c, daily blood glucose readings, dietary intake, and presence of cardiac autonomic neuropathy) and CAD risk factors (lipids, blood pressure, body mass index, waist circumference, and physical activity) will be provided. The presence of anxiety and depression, as well as for the need for referral to another psychiatric professional for ongoing behavioral and/or medication management, will be assessed, facilitated, and followed closely.
Exploratory analyses, aimed at guiding a subsequent randomized controlled trial where the efficacy of the intervention can be ascertained, will be conducted. All procedures will be closely evaluated. Modifications will be made to study protocols and the intervention at study completion.
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