Cardiovascular Disease Education and Problem-Solving Training in People With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to determine if patient education and problem-solving training, delivered in self-study, group, and individual intervention modalities, will produce substantial improvements in CVD risk profile via improved self management in urban African Americans with type 2 diabetes and a high CVD risk profile.

Detailed Description
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African Americans with type 2 diabetes suffer excess disease burden, but cardiovascular disease (CVD) risk factors such as hyperglycemia, hypertension, and dyslipidemia are modifiable with medical management and lifestyle modification. Patient diabetes education and counseling for behavior change are recommended standards of practice to facilitate effective self-management of these risk factors. However, for patients with low literacy or health literacy, accessibility and impact of educational and behavioral interventions are limited. Pilot research suggests that: a) literacy demand and behavioral activation characteristics of patient education modules can be adapted to facilitate learning in urban patients with low literacy, and b) combining literacy-adapted education with problem-solving training facilitates understanding and use of health information for performing self-management in the context of daily life (functional health literacy). Optimal modalities for delivery of a combined patient diabetes education and problem-solving training, and cost-effectiveness of this intervention model, however, are not known. The proposed study will address these needs by testing effectiveness and cost-effectiveness of literacy-adapted diabetes and CVD education and problem-solving training interventions in urban African Americans with type 2 diabetes and high CVD risk profile (suboptimal blood sugar, blood pressure, and/or lipids). The specific aims of the study are: a) to complete development of a package of literacy-adapted diabetes and CVD patient education materials by developing two video/DVDs addressing self-management recommendations appropriate to the needs, resources, and environment of the population; b) to randomize urban African-American adults with type 2 diabetes and a high CVD risk profile into one of four study arms: Usual Care (Arm 1), Literacy-Adapted Education and Problem-Solving Training Self-Study (Arm 2), Literacy-Adapted Education and Group Problem-Solving Training (Arm 3), and Literacy-Adapted Education and Individual Problem-Solving Training (Arm 4); c) to conduct baseline, 3-month post-intervention, and 6-month post-intervention assessment visits to analyze and compare effectiveness of the literacy-adapted education and problem-solving interventions, as compared to Usual Care, in improving the skills of knowledge, problem-solving and health literacy, behaviors of patient activation and diabetes self-management, and clinical outcomes of A1C, blood pressure and lipids; and d) to perform a cost-effectiveness analysis of each intervention arm as compared to Usual Care. If proven effective, this research will yield low literacy diabetes and CVD patient education and self-management intervention tools for dissemination to high-risk urban minority populations. Moreover, the cost-effectiveness analysis will provide evidence to support decision-making regarding implementation of the models to achieve cardiovascular disease patient self-management goals in clinical practice.

Official Title
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Randomized Trial of CVD Education and Problem-Solving Training in Urban Diabetics

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Education + Problem-Solving Training Self-Study
* Behavioral: Education + Group Problem-Solving Training
* Behavioral: Education + Individual Problem-Solving Training
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25 years or older Type 2 diabetes determined by physician diagnosis or self-report of type 2 diabetes confirmed by medical documentation or medication review Black/African American by self-report currently receiving care and able to provide contact information for a treating physician residing in Baltimore, Maryland. Exclusion Criteria: Mentally incompetent to give informed consent Severe cognitive impairment on the Telephone Interview for Cognitive Status Unable to complete assessment (interview, tests, venipuncture) Comorbid conditions likely to lead to death in the next 3-5 years (e.g. cancer, AIDS, end-stage renal disease, active tuberculosis, Alzheimer's disease) Planning to relocate from Baltimore region during the time period of the study or other reasons rendering person unable to attend visits to participate in intervention and follow-up assessments

Ages Eligible for Study
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Minimum Age: 25 Years

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 |
| --- | --- |
| Active Comparator: Usual Care<br>Packet of standard print patient education materials on CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA). | Behavioral: Usual Care<br>* Packet of print patient education materials about CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA)given at baseline following randomization to Arm 1 Scripted set of instructions will be given along with a verbal description of the materials and the content provided.<br>* Other names: Project DECIDE Usual Care;|
| Experimental: Self Study<br>One 90-minute educational session. Print materials and DVDs for self-study | Behavioral: Education + Problem-Solving Training Self-Study<br>* Education + Problem-Solving Training Self-Study One session of Literacy-Adapted Diabetes and CVD Risk Education Instructions and a schedule for use of the Literacy-Adapted Problem-Solving Workbook for self-study will be given to each participant.<br>* Other names: Project DECIDE Self-Study;|
| Experimental: Group Problem-Solving Training<br>One 90-minute education session. Group problem-solving training (eight, 90-minute sessions) | Behavioral: Education + Group Problem-Solving Training<br>* Education + Group Problem-Solving Training One session of the Literacy-Adapted Diabetes and CVD Risk Education Group problem-solving training eight, 90-minute sessions<br>* Other names: Project DECIDE Group Training;|
| Experimental: Individual Problem-Solving Training<br>One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions) | Behavioral: Education + Individual Problem-Solving Training<br>* Education + Individual Problem-Solving Training One session of the Literacy-Adapted Diabetes and CVD Risk Education Individual problem-solving training (eight, 60-minute sessions)<br>* Other names: Project DECIDE Individual Training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | Screening, 3 months post intervention, 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Screening, 3 months post-intervention, 6 months post-intervention | 
| Lipid Panel |  | Screening, 3 months post-intervention, 6 months post-intervention | 
| Body Mass Index |  | Screening, 3 months post-intervention, 6 months post-intervention | 
| Health Problem Solving Scale |  | Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention | 
| Diabetes and CVD Knowledge Test |  | Screening, 3 months post-intervention, 6 months post-intervention | 
| Patient Activation Measure |  | Baseline, 3 months post-intervention, 6 months post-intervention | 
| Summary of Diabetes Self-Care Activities Scale |  | Baseline, 3 months post-intervention, 6 months post-intervention | 
| Barriers to Self-Management |  | Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes self management education, problem-solving training, health behavior change, health literacy