Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial
Using Cues and Rewards in Patients With Arthritis and Rheumatic Disease
2 other identifiers
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2022
CompletedResults Posted
Study results publicly available
October 4, 2023
CompletedOctober 4, 2023
September 1, 2023
1.2 years
February 23, 2021
August 15, 2023
September 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change in Uric Acid Level From Baseline
18 weeks
Study Arms (3)
Control
NO INTERVENTIONPatients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
Cue-Reward Intervention
EXPERIMENTALPatients 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.
Cue-Reward Intervention with possible intensification.
EXPERIMENTALPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- English-speaking patients
- receiving their care at a Brigham and Women's Hospital-affiliated rheumatology practice
- \>=18 years of age
- with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or gout
- prescribed \>=1 oral medication for this disease for \>=4 months.
- for patients with gout, had a uric acid level checked in the prior 18 months and the most recent level is \>6.
- for patients with SLE, their most recent c-reactive protein level collected in the past 18 months must be \>10.
- currently have a smartphone with a data plan or WiFi at home
- willing and able to set up the platform and adhere to study procedures
- either not currently using a pillbox or willing to use electronic pill bottles (EDMs) for diabetes medications for the duration of the study
You may not qualify if:
- Pregnant women
- Incarcerated individuals
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 34819291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Candace Feldman, MD, MPH, ScD
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Candace H Feldman, MD, ScD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 23, 2021
First Posted
March 1, 2021
Study Start
August 2, 2021
Primary Completion
September 27, 2022
Study Completion
November 10, 2022
Last Updated
October 4, 2023
Results First Posted
October 4, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share