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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Education + Individual Problem-Solving Training; Behavioral: Education + Problem-Solving Training Self-Study; Behavioral: Usual Care; Behavioral: Education + Group Problem-Solving Training

• Registration Number: NCT00964587
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Study Start: 2010-08
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual Problem-Solving Training	Education + Individual Problem-Solving Training	One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions)
Self Study	Education + Problem-Solving Training Self-Study	One 90-minute educational session. Print materials and DVDs for self-study
Usual Care	Usual Care	Packet of standard print patient education materials on CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA).
Group Problem-Solving Training	Education + Group Problem-Solving Training	One 90-minute education session. Group problem-solving training (eight, 90-minute sessions)

Primary Outcome Measures

Name	Time	Method
HbA1C	Screening, 3 months post intervention, 6 months post-intervention

Secondary Outcome Measures

Name	Time	Method
Patient Activation Measure	Baseline, 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
Lipid Panel	Screening, 3 months post-intervention, 6 months post-intervention
Body Mass Index	Screening, 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
Blood pressure	Screening, 3 months post-intervention, 6 months post-intervention

Trial Locations

Locations (3)

Johns Hopkins School of Medicine/General Clinical Research Center; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Bayview Medical Center/General Clinical Research Center; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins School of Medicine/General Internal Medicine; 🇺🇸 Baltimore, Maryland, United States