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Completed

NCT Number: NCT03490253

Diabetes and Depression Text Messaging Intervention

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.

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Key information

Conditions

Diabetes Behavior Behavioral Symptoms Depression Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Physical Activity

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital/University of California, San Francisco

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DIAMANTE Adaptive

Behavioral

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 names: Adaptive Mobile Messaging

DIAMANTE Static

Behavioral

The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.

Other names: Static Mobile Messaging

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • University of California, Berkeley

Registry information

Official study title

Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging

Acronym: DIAMANTE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2018
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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