Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial

Using Cues and Rewards in Patients With Arthritis and Rheumatic Disease

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases; Lupus Erythematosus, Systemic; Adherence, Medication; Gout
• Intervention / Treatment: Behavioral: Cue-Reward Intervention; Behavioral: Cue-Reward Intervention with possible intensification

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant women
• Incarcerated individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).
Experimental: Cue-Reward Intervention; 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.	Behavioral: Cue-Reward Intervention; 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.
Experimental: Cue-Reward Intervention with possible intensification.; 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.	Behavioral: Cue-Reward Intervention with possible intensification; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Uric Acid Level From Baseline	Change in uric acid level from baseline	18 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Candace H Feldman, MD, ScD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Actual): September 27, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: 2020P003826; P30AG064199-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No