Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Problem Solving & CVD Risk Management in Diabetic Blacks |
- A1C [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: Yes ]
- Barriers to Self-Management [ Time Frame: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
- Dietary risk assessment [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
- Summary of Diabetes Self-Care Activities Scale [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
- Health Problem-Solving Scale [ Time Frame: baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
- Diabetes and CVD Knowledge Test [ Time Frame: Baseline, 1-week post-intervention follow-up, 3-month post-intervention follow-up ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: Yes ]
- Lipid panel [ Time Frame: Baseline, 3-month post-intervention follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 139 |
| Study Start Date: | July 2004 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Intensive Intervention: CVD Risk Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
|
Behavioral: Problem Solving Skills
Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
|
|
Active Comparator: 2
Brief Intervention: CVD Risk Education (1 session) + Brief Health Problem-Solving Training (1 session)
|
Behavioral: Problem Solving Skills
Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Publications:
| Responsible Party: | Felicia Hill-Briggs, Principal Investigator, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00201110 History of Changes |
| Other Study ID Numbers: | 274, K01HL076644, K01 HL76644 |
| Study First Received: | September 16, 2005 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Johns Hopkins University:
|
African Americans |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Disease Coronary Artery Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013