Viewing Study NCT04776161



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Last Modification Date: 2024-10-26 @ 1:58 PM
Study NCT ID: NCT04776161
Status: COMPLETED
Last Update Posted: 2023-10-04
First Post: 2021-02-23

Brief Title: Medication Adherence Patterns in Rheumatic Diseases A Behavioral Trial
Sponsor: Brigham and Womens Hospital
Organization: Brigham and Womens Hospital

Study Overview

Official Title: Using Cues and Rewards in Patients With Arthritis and Rheumatic Disease
Status: COMPLETED
Status Verified Date: 2023-09
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: None
Brief Summary: Non-adherence to evidence-based prescription medications results in preventable morbidity and mortality for middle-aged and older adults Taking medications intended for daily use like those to prevent or treat chronic conditions is a repetitive action that has great similarity with other behaviors that must be performed consistently such as regular exercise healthy eating and hand washing In these cases people who act consistently do so out of habit The repetition-cue-reward model proposes that habit formation has three central components behavioral repetition associated context cues and rewards This model has obvious applicability to the daily repetitive activity of medication-taking but has not been tested for this behavior nor adapted as an intervention for patients in real-world care settings

The goal of this pilot study is to evaluate the feasibility and effectiveness of using the repetition-cue-reward model of healthy habit formation to improve medication adherence in patients with arthritis and other rheumatic diseases
Detailed Description: Non-adherence to evidence-based prescription medications results in preventable morbidity and mortality for middle-aged and older adults Taking medications intended for daily use like those to prevent or treat chronic conditions is a repetitive action that has great similarity with other behaviors that must be performed consistently such as regular exercise healthy eating and hand washing In these cases people who act consistently do so out of habit The repetition-cue-reward model proposes that habit formation has three central components behavioral repetition associated context cues and rewards This model has obvious applicability to the daily repetitive activity of medication-taking but has not been tested for this behavior nor adapted as an intervention for patients in real-world care settings

The goal of this pilot study is to evaluate the feasibility and effectiveness of using the repetition-cue-reward model of healthy habit formation to improve medication adherence in patients with arthritis and other rheumatic diseases

This pilot study will be a 3-arm parallel randomized pragmatic trial comparing medication adherence for adults over 18 years old with arthritis lupus or gout who are prescribed 1-3 daily oral medications for this disease Participants will be randomized to one of three arms for the duration of the study period Patients in the first intervention arm will choose an event-based cue and receive daily reminder text messages reminding them of their cue Patients in the second intervention arm will start by establishing their cue and having the donation made but only those who show no improvement in adherence after 6 weeks will start receiving the text messages In both interventions arms a donation will be made to a local charity every time they take their medication Patients in the control arm will not receive any intervention but will receive pill bottles to monitor their adherence Our outcomes of interest will be medication adherence as measured by electronic pill bottles

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
P30AG064199-01 NIH None httpsreporternihgovquickSearchP30AG064199-01