Reducing Distress and Improving Self-Care in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups.
研究概览
简要总结
To date, there have been few practical, evidenced based interventions that are directed at patients with Type II Diabetes who are experiencing depressed and/or emotional distress in primary care settings. This study will (1) combine two existing, evidenced-based, interventions (a computer automated, diabetes specific self-management program (CASM) vs. a self-care program plus a live problem solving distress-reduction program (CAPS) vs. a lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention using the RE-AIM framework, sharing the results through a comprehensive dissemination package.
Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on the primary outcomes at follow-up.
Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at follow-up.
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
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of type 2 diabetes (confirmed using the Wellborn criteria for a minimum of 12 months)
- •Be between 21 and 75 years of age
- •Speak and read Spanish or English fluently
- •In addition, based on the telephone screening, patients will have to display a high level of diabetes distress and a deficit in at least one of three self-management areas (diet, physical activity, medication adherence). This is defined as having an average item score > 3.0 on 2 items from the regimen distress and emotional burden sub scale of the DDS and indication of problems in management on at least one scale of the SDSCA (i.e., endorsing having a healthy eating plan on less than 5 days/week, 30 minutes physical activity less than 5 days/week, or forget to take medicines more than 1 day/week).
- •Have access to the internet
排除标准
- •Have major disabilities or severe disorders (MI in the last 12 months, psychosis, on end-stage dialysis, dementia)
- •Have current MDD (based on the PHQ8).
结局指标
主要结局
Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups.
时间窗: Baseline, 16 weeks, and 12 months
Physical Activity. The CHAMPS (28 items) will be used to measure physical activity.
时间窗: Baseline, 16 weeks, and 12 months
Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use.
时间窗: Baseline, 16 weeks, and 12 months
Distress. Patient distress will be assessed across several measures including: the 20-item CES-D, the 17-item DDS, the PHQ8, and screening items from the SCID to rule out psychosis.
时间窗: Baseline, 16 weeks, and 12 months
次要结局
- HbA1C(Baseline, 16 weeks, and 12 months)
- Blood Pressure(Baseline, 16 weeks, and 12 months)
- Fasting glucose(Baseline, 16 weeks, and 12 months)
- Lipids(Baseline, 16 weeks, and 12 months)