Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Physical Activity
研究概览
简要总结
The main aim of the "Diabetes and Mental Health Adaptive Notification Tracking and Evaluation" trial (DIAMANTE) is to test a smartphone intervention that generates adaptive messaging, learning from daily patient data to personalize the timing and type of text-messages. We will compare the adaptive content to 1. a static messaging intervention with health management and educational messages and 2. a control condition that receives a weekly mood message. The primary outcomes for this aim will be improvements in physical activity at 6-month follow-up defined by daily step counts.
详细描述
We utilized user-centered design (UCD) methods to iteratively develop the DIAMANTE content and text messaging system through three iterative phases of UCD with ten patients each (total n=30). The first phase consisted of 1.5-hour individual semi-structured interviews. Findings from phase 1 were used to inform content and information delivery decisions of the final intervention, including selecting the thematic message categories and the design. In the second phase, patients tested out an early prototype of the mobile application through usability testing. Patients tested the final DIAMANTE intervention including thematic message content and the application in the third, final UCD phase, in order to address any user-related issues prior to launching the randomized control trial.
In the DIAMANTE Randomized Controlled Trial, we aim to examine the effect of a smartphone app that uses reinforcement learning to predict the most effective messages for increasing physical activity. We will recruit 276 low-income minority patients with depression and diabetes within he San Francisco Health Network. We will compare this intervention to static messages with health management content, and a control group that only receives a weekly mood message.
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
- Single (Outcomes Assessor)
盲法说明
The investigators and those completing the statistical analyses will not be aware of the true study assignments
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HbA1c (Hemoglobin A1c) > 7
- •PHQ-8 (Patient Health Questionnaire-8) > 5
排除标准
- •high levels of physical activity (>30 minutes of moderate to vigorous activity per day)
- •pregnancy
- •inability to exercise due to physical disability
- •serious mental illness
- •unable to read and write in English or Spanish
- •plans to leave the country for extended periods of time during the trial
研究组 & 干预措施
Static Messaging
We will send patients a total of seven messages per week (one per day) at 10.00 am. For the physical health management messages we use messages from established topics in the Diabetes Prevention Program(23) content with the emphasis on physical activity and stress management. The final message, on the seventh day will ask patients to rate their mood on a scale from 1 to 9. Physical activity (step-count/day) will be passively monitored via the app on their smartphone.
干预措施: DIAMANTE Static (Behavioral)
Adaptive Messaging
Patients in the adaptive messaging arm will receive the daily messages of the static arm, and additionally receive daily messages within different categories of feedback and motivational messages that are chosen using a reinforcement learning (RL) algorithm. Physical activity (step-count/day) will be actively monitored via the app on their smartphone.
干预措施: DIAMANTE Adaptive (Behavioral)
Control Condition
Control patients will only install the app on their phone and will not receive any feedback messages. They will receive one message a week, on a fixed day, asking them to assess their mood in the previous week on a scale of 1 to 9. The message will be sent daily at 10:00 am. Non-responders will receive reminders to submit their mood self-assessments in two hour intervals.
结局指标
主要结局
Physical Activity
时间窗: 6 months
Our primary outcome, change in daily step counts, will be passively collected by a mobile phone application during the time that patients remain in the intervention.
次要结局
- Patient Health Questionnaire-8 (PHQ-8)(6 months)
- Hemoglobin A1c(6 months)