Randomized Trial of CVD Education and Problem-Solving Training in Urban Diabetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 6
- 主要终点
- HbA1C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
HbA1C
时间窗: Screening, 3 months post intervention, 6 months post-intervention
次要结局
- Blood pressure(Screening, 3 months post-intervention, 6 months post-intervention)
- Patient Activation Measure(Baseline, 3 months post-intervention, 6 months post-intervention)
- Health Problem Solving Scale(Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention)
- Diabetes and CVD Knowledge Test(Screening, 3 months post-intervention, 6 months post-intervention)
- Lipid Panel(Screening, 3 months post-intervention, 6 months post-intervention)
- Body Mass Index(Screening, 3 months post-intervention, 6 months post-intervention)
- Summary of Diabetes Self-Care Activities Scale(Baseline, 3 months post-intervention, 6 months post-intervention)
- Barriers to Self-Management(Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention)
研究者
Felicia Hill-Briggs
Assoc. Professor of Medicine
Johns Hopkins University