Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Problem Solving & CVD Risk Management in Diabetic Blacks

Conditions
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Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2, Coronary Disease

Intervention / Treatment
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* Behavioral: Problem Solving Skills
* Behavioral: Problem Solving Skills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 2 diabetes African American by self report High CVD risk profile, defined as having one or more of the following:1) suboptimal A1C (greater than 7 percent); 2) suboptimal blood pressure (SBP greater than 130 mmHg and/or DBP greater than 80 mmHg); 3) suboptimal lipid control (LDL greater than 100 mg and/or HDL less than 40 mg) Willing and able to give informed consent Exclusion Criteria: Plan to leave area prior to study completion Severe diabetes complications that would interfere with the study End-stage disease
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions) | Behavioral: Problem Solving Skills<br>* Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)<br>|
| Active Comparator: 2<br>Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session) | Behavioral: Problem Solving Skills<br>* Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1C |  | Baseline, 3-month post-intervention follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to Self-Management |  | Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up | 
| Dietary risk assessment |  | Baseline, 3-month post-intervention follow-up | 
| Summary of Diabetes Self-Care Activities Scale |  | Baseline, 3-month post-intervention follow-up | 
| Health Problem-Solving Scale |  | baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up | 
| Diabetes and CVD Knowledge Test |  | Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up | 
| Blood pressure |  | Baseline, 3-month post-intervention follow-up | 
| Lipid panel |  | Baseline, 3-month post-intervention follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African Americans