Reinforcement Learning in Diabetes Mellitus Trial

Diabetes Mellitus, Type 2 Clinical Trial

— REINFORCE  

Official title:

Optimizing Message Framing for Healthy Habits for Patients With Type 2 Diabetes - Phase II (Pragmatic Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473326
• Other study ID #: 2020P000846
• Secondary ID: P30AG064199-01
• Status: Completed
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: January 28, 2022

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 this pilot study is to develop and test a novel reinforcement learning-enhanced text messaging program to support medication adherence in patients with type 2 diabetes. Type 2 diabetes is an optimal condition in which to test 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 pilot study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults 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. Our outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels.

Description:

The goal of this pilot study is to develop and test a novel reinforcement learning-enhanced text messaging program to support medication adherence in patients with type 2 diabetes. This pilot study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults 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, untailored text messages. Our outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 28, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

Inclusion criteria:

• Age between 18-84 years
• Diagnosed with type 2 diabetes mellitus (T2DM) and are prescribed between 1-3 daily oral medications for this disease
• Currently have a smartphone with a data plan or WiFi at home
• HbA1c level =7.5%
• Basic working knowledge of English
• Willing and able to set up the platform and adhere to study procedures
• Either not currently using a pillbox or willing to use electronic pill bottles (EDMs) for diabetes medications for the duration of the study

Exclusion criteria:

• Patients with active enrollment in another diabetes trial within Mass General Brigham
• Patients who receive daily assistance with taking their medications at home
• Patients who are unable to receive text messages for more than 3 days in a row during the study period

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Medication Adherence

Intervention

Behavioral:
• Reinforcement Learning
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Medication adherence to type 2 diabetes oral medications (averaged) as measured by the number of dates and times of pillbottle openings in the electronic pill bottles	6 months
Secondary	Glycemic Control	Change in glycated hemoglobin A1c from baseline to end of the 6-month follow-up	6 months