Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Happify Inc.
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in self-reported HbA1C level
研究概览
简要总结
Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires before, during, and after the 8-week program, as well as at 3 months, 6 months, and 12 months after the end of the program.
详细描述
Participants will be randomly assigned to either the Diabetes positive affect skills intervention or a psychoeducation control group. Both programs last 8 weeks and take place on a simplified research version of the Happify platform. Participants assigned to the diabetes positive affect program will have full access to Happify, with a track that focuses on building skills for greater happiness, reducing stress, and coping better with diabetes displayed as the feature track. Participants assigned to the psychoeducation (control) condition will be asked to complete a series of polls on various wellbeing topics, and then provided with some social comparison data about how their responses compared with the responses of other users, as well as information about why the well being topic is important. Participants will be asked to complete questionnaires before, during, and after the 8-week program as well as 3 months, 6 months and 12 months follow-up questionnaires after the program is complete, at which point study participation will end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with Type 2 Diabetes
- •Elevated HbA1c levels (7 or greater)
- •No prior experience on the Happify platform (new user registration)
- •PHQ-8 score of 13 or higher
- •US resident
- •Under the care of a medical professional for the treatment of their diabetes
- •Be willing and able to obtain HbA1c every 3 months
排除标准
- 未提供
结局指标
主要结局
Change in self-reported HbA1C level
时间窗: Baseline, 3 weeks post-intervention (day 83), 3 weeks after 3-month post intervention (day 173), 3 weeks after 6 month post intervention (day 263), and 12 months post intervention (day 416)
1-item self-reported measure of Hemoglobin A1C (HbA1C) level, "What was your most recent HbA1c level?"
次要结局
- Change in Diabetes Regimen Adherence(From baseline up to 63 days, 7 days at 3 months post intervention (146-153), 7 days at 6 months post intervention (236-243), and 12 months post intervention (day 416-423))
- Change in Perceived Stress [Perceived Stress Scale (PSS)](Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention)
- Change in Depression symptoms [PHQ-9 questionnaire](Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention)
- Change in diabetes self-care activities [Summary of Diabetes Self-Care Activities (SDSCA)](Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention)
- Change in positive affect [Patient-Reported Outcomes Measurement Information Systems - Positive Affect Subscale(PROMIS)](Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention)