Depression, Diabetes, Physical Activity
Conditions
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.
Interventions
BEHAVIORALDIAMANTE Adaptive
In a three arm randomized controlled trial we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen by a reinforcement learning algorithm.
BEHAVIORALDIAMANTE Static
The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.
Sponsors
University of California, Berkeley
Agency for Healthcare Research and Quality (AHRQ)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The investigators and those completing the statistical analyses will not be aware of the true study assignments
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed