Clinical trial NCT04776161: Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial
Official title: Using Cues and Rewards in Patients With Arthritis and Rheumatic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Diseases
Gout
Adherence, Medication
Lupus Erythematosus, Systemic
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-03-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Medication Adherence
timeFrame: 18 weeks
Secondary outcomes:
measure: Change in Uric Acid Level From Baseline
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Candace H Feldman, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.