Diabetes and Depression Text Messaging Intervention (DIAMANTE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Physical Activity; Diabetes; Depression

Treatments: Behavioral: DIAMANTE Static; Behavioral: DIAMANTE Adaptive

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03490253

R01HS025429-02 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HbA1c (Hemoglobin A1c) > 7
• PHQ-8 (Patient Health Questionnaire-8) > 5

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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226 participants in 3 patient groups

Static Messaging

Active Comparator group

Description:

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.

Treatment:

Behavioral: DIAMANTE Static

Adaptive Messaging

Experimental group

Description:

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.

Treatment:

Behavioral: DIAMANTE Adaptive

Control Condition

No Intervention group

Description:

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.