Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Problem Solving & CVD Risk Management in Diabetic Blacks
The purpose of this study is to test a measurement tool and a new training intervention for problem solving in self-management of high cardiovascular disease (CVD) risk in African Americans with type 2 diabetes.
BACKGROUND:
African Americans with type 2 diabetes carry a high burden of CVD risk and adverse vascular
events such as stroke and peripheral vascular disease. CVD risk factors of suboptimal blood
pressure, lipids, and glycemic control are controllable through medical management and
lifestyle behavior modification. The traditional primary care medical management model for
these chronic CVD risks is inadequate, and models are shifting toward increased
disease-related decision-making and self-management on the part of the patient. Yet, precise
methods for: 1) identifying patients with ineffective disease-related problem-solving
skills, and 2) providing patients with disease-related education that incorporates
problem-solving and decision-making skills, have yet to be determined
DESIGN NARRATIVE:
The study will test a measurement tool and a novel training intervention for problem solving
as applied to self-management of high CVD risk in African Americans with type 2 diabetes.
The specific aims are to: 1) assess the validity and reliability of an empirically derived
assessment tool of effective versus ineffective CVD risk-related problem-solving ability
(the Health Problem Solving Scale, HPSS), 2) develop a novel intervention to teach CVD
risk-related problem-solving skills to ineffective problem solvers, and 3) conduct a pilot
study with a sample of African Americans with type 2 diabetes who have a high CVD risk
profile (suboptimal blood pressure, lipids, and/or HbA1c) AND ineffective CVD risk-related
problem-solving skills, as measured by the HPSS. The principal investigator is the recipient
of a Research Scientist Development Award. Her career goal is to become an independent
researcher in self-management of CVD risk in high-risk African American populations, and to
be a leader in the development and translation into practice of novel, theory-driven and
empirically based interventions to improve patient self-management of CVD risks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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