Abstract
Introduction/objectivesAdherence to prescribed medication regimens is fundamental to the improvement and maintenance of the health of patients with rheumatoid arthritis. It is therefore important that interventions are developed to address this important health behavior issue. The aim of the present study was to design and evaluate a theory-based intervention to improve the medication adherence (primary outcome) among rheumatoid arthritis patients.MethodsThe study adopted a pre-registered randomized controlled trial design. Rheumatoid arthritis patients were recruited from two University teaching hospitals in Qazvin, Iran from June 2018 to May 2019 and randomly assigned to either an intervention group (n = 100) or a treatment-as-usual group (n = 100). The intervention group received a theory-based intervention designed based on the theoretical underpinnings of the health action process approach (HAPA). More specifically, action planning (making detailed plans to follow medication regimen), coping planning (constructing plans to overcome potential obstacles that may arise in medication adherence), and self-monitoring (using a calendar to record medication adherence) of the HAPA has been used for the treatment. The treatment-as-usual group received standard care.ResultsData analysis was conducted based on the principle of intention to treat. Using a linear mixed-effects model (adjusted for age, sex, medication prescribed, and body mass index), the results showed improved medication adherence scores in the intervention group (loss to follow-up = 16) compared to the treatment-as-usual group (loss to follow-up = 12) at the 3-month (coefficient = 3.9; SE = 0.8) and 6-month (coefficient = 4.5; SE = 0.8) follow-up. Intervention effects on medication adherence scores were found to be mediated by some of the theory-based HAPA variables that guided the study.ConclusionThe results of the present study support the use of a theory-based intervention for improving medication adherence among rheumatoid arthritis patients, a group at-risk of not adhering to medication regimens.Trial registration (in Iranian Registry of Clinical Trials)irct.ir, IRCT20180108038271N1Key Points• Theoretical underpinnings of the health action process approach are useful to improve medication adherence for RA patients.
Highlights
Rheumatoid arthritis (RA) is a chronic autoimmune disorder that affects synovial joints, resulting in severe disability and morbidity [1]
The drug treatment for RA patients is complex, prior research has demonstrated an association between higher medication adherence and better clinical response to therapies in RA patients [10, 11]
The number of disease-modifying antirheumatic drugs (DMARDs) used, disease duration, age, education, marital status, and sex were collected from the medical records of the patients
Summary
Rheumatoid arthritis (RA) is a chronic autoimmune disorder that affects synovial joints, resulting in severe disability and morbidity [1]. The drug treatment for RA patients is complex (e.g., measurement on adherence is difficult to establish and outcomes are dependent on a range of variables), prior research has demonstrated an association between higher medication adherence and better clinical response to therapies in RA patients [10, 11]. Improving medication adherence in RA patients may, in turn, help to improve their health outcomes. Strategies to enhance medication adherence among RA patients are of value to help maximize the efficacy of treatment and minimize the course of RA progression. Sample size was calculated according to the primary outcome measure (i.e., the MARS): that is, whether intervention effects on medication adherence can be detected. Utilizing a 15% attrition rate, it was determined that the sample size of 100 per treatment was needed
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