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

May 11, 2015 updated by: Felicia Hill-Briggs, Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Medicine/General Clinical Research Center
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center/General Clinical Research Center
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins School of Medicine/General Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Behavioral: Usual Care
  • 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
Experimental: Self Study
One 90-minute educational session. Print materials and DVDs for self-study
Behavioral: Education + Problem-Solving Training Self-Study
  • 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
Experimental: Group Problem-Solving Training
One 90-minute education session. Group problem-solving training (eight, 90-minute sessions)
Behavioral: Education + Group Problem-Solving Training
  • 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
Experimental: Individual Problem-Solving Training
One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions)
Behavioral: Education + Individual Problem-Solving Training
  • 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Felicia Hill-Briggs, PhD, ABPP, Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL089751-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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