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

Type 2 Diabetes Clinical Trial

— DECIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964587
• Other study ID #: R01HL089751-01A1
• Secondary ID: R01HL089751-01A1
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: May 11, 2015
• Start date: August 2010
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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
• 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)
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center/General Clinical Research Center	Baltimore	Maryland
United States	Johns Hopkins School of Medicine/General Clinical Research Center	Baltimore	Maryland
United States	Johns Hopkins School of Medicine/General Internal Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Erratum in: Diabetes Educ. 2013 Jul-Aug;39(4):586. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C		Screening, 3 months post intervention, 6 months post-intervention	Yes
Secondary	Blood pressure		Screening, 3 months post-intervention, 6 months post-intervention	Yes
Secondary	Lipid Panel		Screening, 3 months post-intervention, 6 months post-intervention	Yes
Secondary	Body Mass Index		Screening, 3 months post-intervention, 6 months post-intervention	No
Secondary	Health Problem Solving Scale		Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention	No
Secondary	Diabetes and CVD Knowledge Test		Screening, 3 months post-intervention, 6 months post-intervention	No
Secondary	Patient Activation Measure		Baseline, 3 months post-intervention, 6 months post-intervention	No
Secondary	Summary of Diabetes Self-Care Activities Scale		Baseline, 3 months post-intervention, 6 months post-intervention	No
Secondary	Barriers to Self-Management		Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention	No