Refinement and Adaption of Reinforcement Learning to Personalize Behavioral Messaging for Healthy Habits
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Diabetes medication adherence
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Reinforcement Learning Intervention Arm
Up to daily, tailored text messages.
Intervention: Reinforcement Learning (Behavioral)
Control Arm
Up to daily, untailored text messages.
Outcomes
Primary Outcomes
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
- Glycemic control(6 months)
Investigators
Julie Lauffenburger
Assistant Professor
Brigham and Women's Hospital