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Improving Adherence and Outcomes by Artificial Intelligence-Adapted Text Messages

NCT02454660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-04-11

No results posted yet for this study

Summary

Uncontrolled hypertension is a major cause of morbidity and mortality and many patients fail to take their antihypertensive medication as prescribed. The investigators propose to use artificial intelligence (AI) to allow short message service (SMS or text messages) interventions to adapt to patients' adherence needs and substantially improve medication taking. The aims of the study are to: (1) develop AI methods for adaptive decision-making in human-centered environments and demonstrate the feasibility of the resulting AI-enhanced SMS medication adherence intervention, (2) demonstrate that the intervention can "learn" by adapting the SMS message stream according to patients' medication taking over time, and (3) examine potential intervention impact as measured by improvements in medication adherence and systolic blood pressures. The investigators will recruit 100 patients with uncontrolled hypertension and antihypertensive medication non-adherence. Adherence and other covariates will be measured via surveys at baseline, 3- and 6 months; blood pressures will be measured at baseline and 6 months. Participants will be given an electronic pill-bottle adherence monitor. Participants will receive SMS messages designed to motivate antihypertensive medication adherence. Message content and frequency will adapt automatically using AI algorithms designed to automatically optimize expected pill bottle opening. For Aim 1, the first 25 patients will be enrolled to develop and test alternative RL algorithms and fine-tune the system parameters. For Aim 2, the investigators will examine changes in the probability distribution over message-types and compare that distribution with patients' reasons for non-adherence reported at baseline. For Aim 3, the investigators will examine changes in self-reported medication non-adherence and blood pressure and automatically-reported pill bottle openings. This pilot study will establish the feasibility and potential impact of this novel approach to mobile health messaging for self-management support. The results will be used to support an R01 application for a larger and more definitive trial of intervention impacts.

Conditions

  • Medication Non-adherence

Interventions

BEHAVIORAL

SMS (Text messages)

Up to 1 text message a day. The artificial agent will determine whether to send a message each day. If it sends a message, it will also determine which of five message types to send.

Sponsors & Collaborators

Principal Investigators

  • Karen Farris, PhD · Univerity of Michigan, College of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-11-04
Completion
2016-11-04

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02454660 on ClinicalTrials.gov