Reinforcement Learning in Diabetes Mellitus Trial

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04473326
Collaborator
National Institute on Aging (NIA) (NIH)
60
Enrollment
1
Location
2
Arms
12.4
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

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 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Reinforcement Learning
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Optimizing Message Framing for Healthy Habits for Patients With Type 2 Diabetes - Phase II (Pragmatic Trial)
Actual Study Start Date :
Feb 4, 2021
Anticipated Primary Completion Date :
Jan 4, 2022
Anticipated Study Completion Date :
Feb 15, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Reinforcement Learning Intervention Arm

Up to daily, tailored text messages.

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.

No Intervention: Control Arm

Up to daily, untailored text messages.

Outcome Measures

Primary Outcome Measures

  1. Medication adherence [6 months]

    Medication adherence to one to three type 2 diabetes treatments as measured by electronic pill bottles

Secondary Outcome Measures

  1. Glycemic control [6 months]

    Change in glycosylated hemoglobin A1c from baseline to follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Brigham and Women's HospitalBostonMassachusettsUnited States02120

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Julie Lauffenburger, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04473326
Other Study ID Numbers:
  • 2020P000846
  • P30AG064199-01
First Posted:
Jul 16, 2020
Last Update Posted:
Oct 7, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021