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Refinement and Adaption of Reinforcement Learning to Personalize Behavioral Messaging for Healthy Habits (REINFORCE2)

Primary Purpose

Diabetes Mellitus, Type 2, Medication Adherence

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reinforcement Learning
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus (T2DM) Prescribed between 1-3 daily oral medications for diabetes Most recent HbA1c level of 7.5% or greater Suboptimal adherence, defined by proportion of days covered (PDC) < 0.80 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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reinforcement Learning Intervention Arm

Control Arm

Arm Description

Up to daily, tailored text messages.

Up to daily, untailored text messages.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2023
Last Updated
August 29, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Boston Medical Center, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05742685
Brief Title
Refinement and Adaption of Reinforcement Learning to Personalize Behavioral Messaging for Healthy Habits
Acronym
REINFORCE2
Official Title
Refinement and Adaption of Reinforcement Learning to Personalize Behavioral Messaging for Healthy Habits
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Boston Medical Center, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Medication Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reinforcement Learning Intervention Arm
Arm Type
Experimental
Arm Description
Up to daily, tailored text messages.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Up to daily, untailored text messages.
Intervention Type
Behavioral
Intervention Name(s)
Reinforcement Learning
Intervention Description
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 Outcome Measure Information:
Title
Diabetes medication adherence
Description
Proportion of correct doses recorded by electronic pill bottles in the 6-month follow-up period, averaged across study medications
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Glycemic control
Description
Change between baseline HbA1c used for identification and the 6-month intervention period, using laboratory values in the EHR
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus (T2DM) Prescribed between 1-3 daily oral medications for diabetes Most recent HbA1c level of 7.5% or greater Suboptimal adherence, defined by proportion of days covered (PDC) < 0.80 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
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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