Diabetes and Depression Text Messaging Intervention
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 350
Summary
- Conditions
- Depression
- Diabetes
- Physical Activity
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study is a randomized, controlled, one-center superiority trial with three-arm groups and a primary endpoint of increase in daily steps during a 6 month intervention by a smartphone app. Randomization will be performed as block randomization with a 1:1:1 allocation. Patients will be automatically randomized into groups trough our secure server during on-boarding of the app. Patients need to be informed of the nature and frequency of the messages they will be receiving and discuss this with investigators during the course of the study. Therefore, investigators and patients will not be blinded. We used the SPIRIT checklist when writing our report.Masking: Single (Outcomes Assessor)Masking Description: The investigators and those completing the statistical analyses will not be aware of the true study assignmentsPrimary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT03490253
- Collaborators
- University of California, Berkeley
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Principal Investigator: Courtney Lyles, PhD University of California, San Francisco Principal Investigator: Adrian Aguilera, PhD UC Berkeley
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