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Diabetes and Depression Text Messaging Intervention (DIAMANTE)

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ClinicalTrials.gov Identifier: NCT03490253
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 28, 2021
Sponsor:
Collaborators:
University of California, Berkeley
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE April 6, 2018
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE February 5, 2020
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
Physical Activity [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Physical Activity [ Time Frame: 6 months ]
Total change in daily steps assessed via smartphone pedometer application
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
  • Hemoglobin A1c [ Time Frame: 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) [ Time Frame: 6 months ]
    We will compare the self-reported PHQ-8 from medical records at baseline, intervention completion, and at the 6 month follow-up.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Hemoglobin A1c [ Time Frame: 6 months ]
    Diabetes control measure assessed via blood work for diabetes patients, usually every 3 months during regular clinical visits. An A1c>7% is considered high.
  • Patient Health Questionnaire-9 [ Time Frame: 6 months ]
    Depressive symptoms assessed via 9-item survey measure, with a score of 0-27 (10 or higher indicating moderate or severe symptoms)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diabetes and Depression Text Messaging Intervention
Official Title  ICMJE Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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)
Masking Description:
The investigators and those completing the statistical analyses will not be aware of the true study assignments
Primary Purpose: Other
Condition  ICMJE
  • Diabetes
  • Depression
  • Physical Activity
Intervention  ICMJE
  • Behavioral: DIAMANTE 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.
    Other Name: Adaptive Mobile Messaging
  • Behavioral: DIAMANTE Static
    The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.
    Other Name: Static Mobile Messaging
Study Arms  ICMJE
  • Active Comparator: Static Messaging
    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.
    Intervention: Behavioral: DIAMANTE Static
  • Experimental: Adaptive Messaging
    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.
    Intervention: Behavioral: DIAMANTE Adaptive
  • No Intervention: Control Condition
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2019)
276
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
350
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Courtney Lyles, PhD (628) 206-6483 courtney.lyles@ucsf.edu
Contact: Faviola Garcia, BA (628) 206-2994 faviola.garcia@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03490253
Other Study ID Numbers  ICMJE R01HS025429-02( U.S. AHRQ Grant/Contract )
R01HS025429-02 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
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.
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • University of California, Berkeley
  • Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Courtney Lyles, PhD University of California, San Francisco
Principal Investigator: Adrian Aguilera, PhD UC Berkeley
PRS Account University of California, San Francisco
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP