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临床试验/NCT05742685
NCT05742685已完成不适用

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

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年8月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Diabetes medication adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Reinforcement Learning Intervention Arm

Experimental

Up to daily, tailored text messages.

干预措施: Reinforcement Learning (Behavioral)

Control Arm

No Intervention

Up to daily, untailored text messages.

结局指标

主要结局

Diabetes medication adherence

时间窗: 6 months

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

次要结局

  • Glycemic control(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Lauffenburger

Assistant Professor

Brigham and Women's Hospital

研究点 (1)

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