Diabetes and Depression Text Messaging Intervention
Condition: Diabetes; Depression; Physical Activity
MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): DIAMANTE Adaptive; DIAMANTE Static
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.
Other intervention name(s): Adaptive Mobile Messaging; Static Mobile Messaging
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Other