Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742685
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-04
First Post:
2023-02-15
Brief Title:
Refinement and Adaption of Reinforcement Learning to Personalize Behavioral Messaging for Healthy Habits
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Refinement and Adaption of Reinforcement Learning to Personalize Behavioral Messaging for Healthy Habits
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REINFORCE2
Brief Summary:
Reinforcement learning is an advanced analytic method that discovers each individuals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG064199-04 | NIH | None | httpsreporternihgovquickSearchP30AG064199-04 |