An interventional study of DIAMANTE Adaptive and DIAMANTE Static in Diabetes, Depression and Physical Activity, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Other
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.
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.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 226 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
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Exclusion Criteria:
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.
Behavioral: DIAMANTE Static
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.
Behavioral: DIAMANTE Adaptive
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.
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.
Also known as: Adaptive Mobile Messaging
The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.
Also known as: Static Mobile Messaging
Physical Activity
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.
Time frame: 6 months
Hemoglobin A1c
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.
Time frame: 6 months
Patient Health Questionnaire-8 (PHQ-8)
We will compare the self-reported PHQ-8 from medical records at baseline, intervention completion, and at the 6 month follow-up.
Time frame: 6 months
Plan to share: Yes — We will submit study-results for publication in peer reviewed journals and presentation at (inter)national meetings, taking into account relevant reporting guidelines (e.g. CONSORT(32)). We will attempt to publish all findings in open-access journals when possible, or in other journals with a concurrent uploading of the manuscript content into PubMed Central for public access. Curated technical appendices, statistical code, and anonymized data will become freely available from the corresponding authors upon request.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Within 1-3 years after the end of the trial.
Access criteria: Curated technical appendices, statistical code, and anonymized data will become freely available from the corresponding authors upon request.
Ran from Feb 2020 to primary completion in Dec 2022, 34 months.
Of 2,196 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 34 months is above that.
Counting every sponsor, half of 2,388 studies reached it within 20 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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