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

NCT ID: NCT00964587

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-02-28

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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.

Self Study

One 90-minute educational session. Print materials and DVDs for self-study

Group Type: EXPERIMENTAL

Education + Problem-Solving Training Self-Study

Intervention Type: 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.

Group Problem-Solving Training

One 90-minute education session. Group problem-solving training (eight, 90-minute sessions)

Group Type: EXPERIMENTAL

Education + Group Problem-Solving Training

Intervention Type: 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

Individual Problem-Solving Training

One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions)

Group Type: EXPERIMENTAL

Education + Individual Problem-Solving Training

Intervention Type: 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)

Interventions

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.

Intervention Type: 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

Intervention Type: 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)

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Self-Management Training Self-Study; Project DECIDE Self-Study; Group Self-Management Training; Project DECIDE Group Training; Individual Self-Management Training; Project DECIDE Individual Training; Standard Print Education Materials; Project DECIDE Usual Care

Eligibility 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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Felicia Hill-Briggs

Assoc. Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felicia Hill-Briggs, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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

Countries

United States

References

Hill-Briggs F, Gemmell L. Problem solving in diabetes self-management and control: a systematic review of the literature. Diabetes Educ. 2007 Nov-Dec;33(6):1032-50; discussion 1051-2. doi: 10.1177/0145721707308412.

Reference Type: BACKGROUND

PMID: 18057272 (View on PubMed)

Hill-Briggs F, Smith AS. Evaluation of diabetes and cardiovascular disease print patient education materials for use with low-health literate populations. Diabetes Care. 2008 Apr;31(4):667-71. doi: 10.2337/dc07-1365. Epub 2008 Jan 17.

Reference Type: BACKGROUND

PMID: 18202245 (View on PubMed)

Hill-Briggs F, Gemmell L, Kulkarni B, Klick B, Brancati FL. Associations of patient health-related problem solving with disease control, emergency department visits, and hospitalizations in HIV and diabetes clinic samples. J Gen Intern Med. 2007 May;22(5):649-54. doi: 10.1007/s11606-006-0091-2.

Reference Type: BACKGROUND

PMID: 17443373 (View on PubMed)

Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behav Med. 2003 Summer;25(3):182-93. doi: 10.1207/S15324796ABM2503_04.

Reference Type: BACKGROUND

PMID: 12763713 (View on PubMed)

Hill-Briggs F, Renosky R, Lazo M, Bone L, Hill M, Levine D, Brancati FL, Peyrot M. Development and pilot evaluation of literacy-adapted diabetes and CVD education in urban, diabetic African Americans. J Gen Intern Med. 2008 Sep;23(9):1491-4. doi: 10.1007/s11606-008-0679-9. Epub 2008 Jun 3.

Reference Type: BACKGROUND

PMID: 18521688 (View on PubMed)

Majid HM, Schumann KP, Doswell A, Sutherland J, Hill Golden S, Stewart KJ, Hill-Briggs F. Development and evaluation of the DECIDE to move! Physical activity educational video. Diabetes Educ. 2012 Nov-Dec;38(6):855-9. doi: 10.1177/0145721712462748. Epub 2012 Oct 4.

Reference Type: BACKGROUND

PMID: 23042504 (View on PubMed)

Hill-Briggs F, Schumann KP, Dike O. Five-step methodology for evaluation and adaptation of print patient health information to meet the < 5th grade readability criterion. Med Care. 2012 Apr;50(4):294-301. doi: 10.1097/MLR.0b013e318249d6c8.

Reference Type: BACKGROUND

PMID: 22354210 (View on PubMed)

Fitzpatrick SL, Schumann KP, Hill-Briggs F. Problem solving interventions for diabetes self-management and control: a systematic review of the literature. Diabetes Res Clin Pract. 2013 May;100(2):145-61. doi: 10.1016/j.diabres.2012.12.016. Epub 2013 Jan 9.

Reference Type: BACKGROUND

PMID: 23312614 (View on PubMed)

Fitzpatrick SL, Golden SH, Stewart K, Sutherland J, DeGross S, Brown T, Wang NY, Allen J, Cooper LA, Hill-Briggs F. Effect of DECIDE (Decision-making Education for Choices In Diabetes Everyday) Program Delivery Modalities on Clinical and Behavioral Outcomes in Urban African Americans With Type 2 Diabetes: A Randomized Trial. Diabetes Care. 2016 Dec;39(12):2149-2157. doi: 10.2337/dc16-0941.

Reference Type: DERIVED

PMID: 27879359 (View on PubMed)

Other Identifiers

R01HL089751-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R01HL089751-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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