Diabetes and Depression Text Messaging Intervention

Not Applicable

Completed

Brief Summary: 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.

Detailed 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 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Adaptive Messaging	DIAMANTE Adaptive	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.
Static Messaging	DIAMANTE Static	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity	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.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-8 (PHQ-8)	6 months	We will compare the self-reported PHQ-8 from medical records at baseline, intervention completion, and at the 6 month follow-up.
Hemoglobin A1c	6 months	We will derive HbA1c, the average plasma glucose over the previous eight to 12 weeks, recommended as a means to diagnose diabetes (20), from patients' electronic health records (EHR). We will use the most recent, available measurement from a maximum of 12 months before participating in the study. After 6 months, we will again assess the most recent HbA1c (pulling from patients EHR), ensuring that at least 3 months elapsed between baseline and follow-up HbA1c levels.

Locations (1): Zuckerberg San Francisco General Hospital/University of California, San Francisco
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San Francisco, California, United States