An interventional study of Education + Problem-Solving Training Self-Study and Education + Group Problem-Solving Training in Type 2 Diabetes, sponsored by Johns Hopkins University. Completed at 3 sites in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 382 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 25 years or older
Exclusion Criteria:
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
One 90-minute educational session. Print materials and DVDs for self-study
Behavioral: Education + Problem-Solving Training Self-Study
One 90-minute education session. Group problem-solving training (eight, 90-minute sessions)
Behavioral: Education + Group Problem-Solving Training
One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions)
Behavioral: Education + Individual Problem-Solving Training
* 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.
Also known as: Self-Management Training Self-Study, Project DECIDE Self-Study
* Education + Group Problem-Solving Training * One session of the Literacy-Adapted Diabetes and CVD Risk Education * Group problem-solving training eight, 90-minute sessions
Also known as: Group Self-Management Training, Project DECIDE Group 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)
Also known as: Individual Self-Management Training, Project DECIDE Individual Training
* 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.
Also known as: Standard Print Education Materials, Project DECIDE Usual Care
HbA1C
Time frame: Screening, 3 months post intervention, 6 months post-intervention
Blood pressure
Time frame: Screening, 3 months post-intervention, 6 months post-intervention
Lipid Panel
Time frame: Screening, 3 months post-intervention, 6 months post-intervention
Body Mass Index
Time frame: 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
Diabetes and CVD Knowledge Test
Time frame: Screening, 3 months post-intervention, 6 months post-intervention
Patient Activation Measure
Time frame: 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
Barriers to Self-Management
Time frame: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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