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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00201110 |
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.
Condition | Intervention |
---|---|
Cardiovascular Diseases Heart Diseases Diabetes Mellitus, Type 2 Coronary Disease |
Behavioral: Problem Solving Skills |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Problem Solving & CVD Risk Management in Diabetic Blacks |
Estimated Enrollment: | 200 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
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Behavioral: Problem Solving Skills
Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
|
2: Active Comparator
Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)
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Behavioral: Problem Solving Skills
Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
|
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins School of Medicine/General Clinical Research Center | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Felicia Hill-Briggs, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University School of Medicine ( Felicia Hill-Briggs, PhD ) |
Study ID Numbers: | 274, K01 HL76644 |
Study First Received: | September 16, 2005 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00201110 |
Health Authority: | United States: Federal Government |
African Americans |
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases Ischemia |
Arteriosclerosis Coronary Disease Diabetes Mellitus, Type 2 Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Coronary Artery Disease |
Cardiovascular Diseases |