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Completed

NCT Number: NCT00964587

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

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education + Problem-Solving Training Self-Study

Behavioral
  • 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.

Other names: Self-Management Training Self-Study, Project DECIDE Self-Study

Education + Group Problem-Solving Training

Behavioral
  • Education + Group Problem-Solving Training
  • One session of the Literacy-Adapted Diabetes and CVD Risk Education
  • Group problem-solving training eight, 90-minute sessions

Other names: Group Self-Management Training, Project DECIDE Group Training

Education + Individual Problem-Solving Training

Behavioral
  • Education + Individual Problem-Solving Training
  • One session of the Literacy-Adapted Diabetes and CVD Risk Education
  • Individual problem-solving training (eight, 60-minute sessions)

Other names: Individual Self-Management Training, Project DECIDE Individual Training

Usual Care

Behavioral
  • 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.

Other names: Standard Print Education Materials, Project DECIDE Usual Care

Primary outcomes

  1. HbA1C

    Time frame: Screening, 3 months post intervention, 6 months post-intervention

Secondary outcomes

  1. Blood pressure

    Time frame: Screening, 3 months post-intervention, 6 months post-intervention

  2. Lipid Panel

    Time frame: Screening, 3 months post-intervention, 6 months post-intervention

  3. Body Mass Index

    Time frame: Screening, 3 months post-intervention, 6 months post-intervention

  4. Health Problem Solving Scale

    Time frame: Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention

  5. Diabetes and CVD Knowledge Test

    Time frame: Screening, 3 months post-intervention, 6 months post-intervention

  6. Patient Activation Measure

    Time frame: Baseline, 3 months post-intervention, 6 months post-intervention

  7. Summary of Diabetes Self-Care Activities Scale

    Time frame: Baseline, 3 months post-intervention, 6 months post-intervention

  8. Barriers to Self-Management

    Time frame: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: DECIDE

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 25, 2009
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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