N/A N=62 Randomized Double-blind Health Services Research

Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial

Rheumatic Diseases · Gout · Adherence, Medication · Lupus Erythematosus, Systemic

Bottom Line

View on ClinicalTrials.gov: NCT04776161 ↗

Enrolled (actual)

Serious AEs

10.7%

Results posted

Oct 2023

Primary outcome: Primary: Rate of Medication Adherence — 0.76; 0.79; 0.83 percentage of doses taken — p=0.78

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cue-Reward Intervention (Behavioral); Cue-Reward Intervention with possible intensification (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Medication Adherence	0.76; 0.79; 0.83	0.78
SECONDARY Change in Uric Acid Level From Baseline	-1.21; -1.13; -0.55	0.22

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04776161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.