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临床试验/NCT03490253
NCT03490253已完成不适用

Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2020年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
226
试验地点
2
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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