NCT04776161|CompletedResults
Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial
Using Cues and Rewards in Patients With Arthritis and Rheumatic Disease
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Using Cues and Rewards in Patients With Arthritis and Rheumatic Disease
Sponsor study identifier
Secondary identifiers
interventional
62
1 country
1
Study Start
August 2, 2021
Actual (reported)Primary Completion
September 27, 2022
Actual (reported)Study Completion
November 10, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 10, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 23, 2021
Actual (reported)March 1, 2021
Actual (reported)August 2, 2021
Actual (reported)September 27, 2022
Actual (reported)November 10, 2022
Actual (reported)October 4, 2023
Actual (reported)Rate of Medication Adherence
Medication adherence will be measured as the percentage of times a patient opened the electronic pill bottle out of the number of doses prescribed for each bottle in each day, averaged across the study medications and over follow-up.
18 weeks
Change in Uric Acid Level From Baseline
18 weeks
Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
Patients in this intervention arm will choose an event-based cue and receive reminder text messages reminding them of their cue. Additionally, a donation will be made to a local charity every time they take their medication.
Patients in this intervention arm will choose an event-based cue. Additionally, a donation will be made to a local charity every time they take their medication. Those who show no improvement in adherence after 6 weeks will start receiving reminder text messages reminding them of their cue.
Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Fontanet CP, Choudhry NK, Wood W, Robertson T, Haff N, Oran R, Sears ES, Kim E, Hanken K, Barlev RA, Lauffenburger JC, Feldman CH. Randomised controlled trial targeting habit formation to improve medication adherence to daily oral medications in patients with gout. BMJ Open. 2021 Nov 24;11(11):e055930. doi: 10.1136/bmjopen-2021-055930.
Candace H Feldman, MD, ScD
Brigham and Women's Hospital
62 participants (actual enrollment reported by the registry).
First Submitted
February 23, 2021
First Posted
March 1, 2021
Study Start
August 2, 2021
Actual (reported)Electronic Medication Adherence Reporting and Feedback During Care Transitions
Behavioral Economics to Improve Antihypertensive Therapy Adherence
Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf. After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 27, 2022
Actual (reported)Study Completion
November 10, 2022
Actual (reported)Last Updated
October 4, 2023
Results First Posted
October 4, 2023
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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