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

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Treatment

Reinforcement Learning

Clinical Study ID

NCT05742685

2023P000293

P30AG064199-04

Ages 18-84
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 onchart review
Must have a smartphone for which they are the sole user
Must have a basic working knowledge of English or Spanish

Exclusion

Exclusion Criteria:

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

Study Design

Reinforcement Learning

August 23, 2023

December 17, 2025

Study 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.

Connect with a study center

Boston Medical Center
Boston, Massachusetts 02118
United States
Site Not Available
Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
United States
Site Not Available

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