Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial

Mass General Brigham

Status: Completed

Conditions: Lupus Erythematosus, Systemic; Adherence, Medication; Rheumatic Diseases; Gout

Treatments: Behavioral: Cue-Reward Intervention; Behavioral: Cue-Reward Intervention with possible intensification

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04776161

P30AG064199-01 (U.S. NIH Grant/Contract)

2020P003826

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 3 patient groups

Control

No Intervention group

Description:

Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence).

Cue-Reward Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Cue-Reward Intervention

Cue-Reward Intervention with possible intensification.

Experimental group

Description:

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.

Treatment:

Behavioral: Cue-Reward Intervention with possible intensification