Clinical Trials Directory

Trials / Completed

CompletedNCT05742685

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
All
Age
18 Years – 84 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALReinforcement LearningParticipants 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.

Timeline

Start date
2023-08-23
Primary completion
2025-12-17
Completion
2025-12-17
First posted
2023-02-24
Last updated
2026-03-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05742685. Inclusion in this directory is not an endorsement.