Cardiovascular Disease Education and Problem-Solving Training in People With Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Diabetes |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | August 2010 |
End Date: | March 2013 |
Contact: | Angela Doswell, BS |
Email: | angela.doswell@jhu.edu |
Phone: | 410-502-0662 |
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.
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.
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
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