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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 : March 2, 2020
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Diabetes Depression Physical Activity Behavioral: DIAMANTE Adaptive Behavioral: DIAMANTE Static Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
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 onboarding 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
Official Title: Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490253


Contacts
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Contact: Courtney Lyles, PhD (628) 206-6483 courtney.lyles@ucsf.edu
Contact: Faviola Garcia, BA (628) 206-2994 faviola.garcia@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital/University of California, San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Faviola Garcia, BA       Faviola.Garcia@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
University of California, Berkeley
Investigators
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Principal Investigator: Courtney Lyles, PhD University of California, San Francisco
Principal Investigator: Adrian Aguilera, PhD UC Berkeley
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03490253    
Other Study ID Numbers: R01HS025429-02 ( U.S. AHRQ Grant/Contract )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders