Diabetes and Depression Text Messaging Intervention

Depression Clinical Trial

— DIAMANTE  

Official title:

Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490253
• Other study ID #: R01HS025429-02
• Secondary ID: R01HS025429-02
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes
• Diabetes Mellitus
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital/University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Agency for Healthcare Research and Quality (AHRQ), University of California, Berkeley

Country where clinical trial is conducted

United States, 

References & Publications (8)

Aguilera A, Figueroa CA, Hernandez-Ramos R, Sarkar U, Cemballi A, Gomez-Pathak L, Miramontes J, Yom-Tov E, Chakraborty B, Yan X, Xu J, Modiri A, Aggarwal J, Jay Williams J, Lyles CR. mHealth app using machine learning to increase physical activity in diab — View Citation

Aguilera A, Schueller SM, Leykin Y. Daily mood ratings via text message as a proxy for clinic based depression assessment. J Affect Disord. 2015 Apr 1;175:471-4. doi: 10.1016/j.jad.2015.01.033. Epub 2015 Jan 29. — View Citation

Avila-Garcia P, Hernandez-Ramos R, Nouri SS, Cemballi A, Sarkar U, Lyles CR, Aguilera A. Engaging users in the design of an mHealth, text message-based intervention to increase physical activity at a safety-net health care system. JAMIA Open. 2019 Oct 11; — View Citation

Figueroa CA, Aguilera A, Chakraborty B, Modiri A, Aggarwal J, Deliu N, Sarkar U, Jay Williams J, Lyles CR. Adaptive learning algorithms to optimize mobile applications for behavioral health: guidelines for design decisions. J Am Med Inform Assoc. 2021 Jun — View Citation

Figueroa CA, Deliu N, Chakraborty B, Modiri A, Xu J, Aggarwal J, Jay Williams J, Lyles C, Aguilera A. Daily Motivational Text Messages to Promote Physical Activity in University Students: Results From a Microrandomized Trial. Ann Behav Med. 2022 Feb 11;56 — View Citation

Hernandez-Ramos R, Aguilera A, Garcia F, Miramontes-Gomez J, Pathak LE, Figueroa CA, Lyles CR. Conducting Internet-Based Visits for Onboarding Populations With Limited Digital Literacy to an mHealth Intervention: Development of a Patient-Centered Approach — View Citation

Lyles CR, Ratanawongsa N, Bolen SD, Samal L. mHealth and Health Information Technology Tools for Diverse Patients with Diabetes. J Diabetes Res. 2017;2017:1704917. doi: 10.1155/2017/1704917. Epub 2017 Feb 23. No abstract available. — View Citation

Nouri SS, Avila-Garcia P, Cemballi AG, Sarkar U, Aguilera A, Lyles CR. Assessing Mobile Phone Digital Literacy and Engagement in User-Centered Design in a Diverse, Safety-Net Population: Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Aug 29;7(8):e14250. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months