Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Felicia Hill-Briggs, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00964587
First received: August 24, 2009
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Education + Problem-Solving Training Self-Study
Behavioral: Education + Group Problem-Solving Training
Behavioral: Education + Individual Problem-Solving Training
Behavioral: Usual Care

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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • HbA1C [ Time Frame: Screening, 3 months post intervention, 6 months post-intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Screening, 3 months post-intervention, 6 months post-intervention ] [ Designated as safety issue: Yes ]
  • Lipid Panel [ Time Frame: Screening, 3 months post-intervention, 6 months post-intervention ] [ Designated as safety issue: Yes ]
  • Body Mass Index [ Time Frame: Screening, 3 months post-intervention, 6 months post-intervention ] [ Designated as safety issue: No ]
  • Health Problem Solving Scale [ Time Frame: Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention ] [ Designated as safety issue: No ]
  • Diabetes and CVD Knowledge Test [ Time Frame: Screening, 3 months post-intervention, 6 months post-intervention ] [ Designated as safety issue: No ]
  • Patient Activation Measure [ Time Frame: Baseline, 3 months post-intervention, 6 months post-intervention ] [ Designated as safety issue: No ]
  • Summary of Diabetes Self-Care Activities Scale [ Time Frame: Baseline, 3 months post-intervention, 6 months post-intervention ] [ Designated as safety issue: No ]
  • Barriers to Self-Management [ Time Frame: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 610
Study Start Date: August 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • 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
  • 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
  • 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

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964587

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center/General Clinical Research Center
Baltimore, Maryland, United States, 21224
Johns Hopkins School of Medicine/General Clinical Research Center
Baltimore, Maryland, United States, 21205
Johns Hopkins School of Medicine/General Internal Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Felicia Hill-Briggs, PhD, ABPP Johns Hopkins School of Medicine
  More Information

Publications:

Responsible Party: Felicia Hill-Briggs, Assoc. Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00964587     History of Changes
Other Study ID Numbers: R01 HL089751-01A1, R01HL089751-01A1
Study First Received: August 24, 2009
Last Updated: March 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
diabetes self management education
problem-solving training
health behavior change
health literacy

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014