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OpenTrials
Completed

NCT Number: NCT05742685

Refinement and Adaption of Reinforcement Learning to Personalize Behavioral Messaging for Healthy Habits

Reinforcement learning is an advanced analytic method that discovers each individual's pattern of responsiveness by observing their actions and then implements a personalized strategy to optimize individuals' behaviors using trial and error. The goal of the proposed research is to refine, adapt and perform efficacy testing of a novel reinforcement learning-based text messaging intervention to support medication adherence for patients with type 2 diabetes within a community health center setting. This study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults in a community setting aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: (1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment-response patterns; or (2) a control arm with up to daily, un-tailored text messages. Outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels over 6 months.

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Key information

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

The goal of the proposed research is to refine, adapt and perform efficacy testing of a novel reinforcement learning-based text messaging intervention to support medication adherence for patients with type 2 diabetes within a community setting. Type 2 diabetes is an optimal condition in which to refine this program, as it is one of the most prevalent chronic conditions in the US adult population and requires most patients to be on daily or twice daily doses of medications. This study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults in a community setting aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: (1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment-response patterns; or (2) a control arm with up to daily, un-tailored text messages. Outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels over 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Type 2 Diabetes Mellitus (T2DM)
  • Prescribed between 1-3 daily oral medications for diabetes
  • Most recent HbA1c level of 7% or greater
  • Suboptimal adherence, defined by proportion of days covered (PDC) < 0.90 based on chart review
  • Must have a smartphone for which they are the sole user
  • Must have a basic working knowledge of English or Spanish

Exclusion criteria

  • Currently using a pillbox and/or not willing to use electronic pill bottles for 6 months
  • Receive help at home on a daily basis with taking medications

Treatment and study plan

Reinforcement Learning

Behavioral

Participants in the intervention arm will receive up to daily, tailored text messages based on their electronic pill bottle-measured adherence. Given the participants' baseline characteristics and time-varying responses to the messages, a reinforcement learning algorithm will deliver different text messages and adapt over time to determine which type of messaging works best for each individual participant.

Primary outcomes

  1. Diabetes medication adherence

    Time frame: 6 months

    Proportion of correct doses recorded by electronic pill bottles in the 6-month follow-up period, averaged across study medications

Secondary outcomes

  1. Glycemic control

    Time frame: 6 months

    Change between baseline HbA1c used for identification and the 6-month intervention period, using laboratory values in the EHR

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boston Medical Center
  • National Institute on Aging (NIA)

Registry information

Acronym: REINFORCE2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2023
Registry last updated
Mar 20, 2026

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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