The Remote Monitoring of Rheumatoid Arthritis (REMORA) trial is underway to assess the effectiveness of integrating a symptom tracking app into routine clinical care for patients with rheumatoid arthritis (RA). This multi-center trial, conducted across 16 rheumatology outpatient departments, aims to determine if incorporating patient-reported symptom data into electronic health records can improve disease management and patient outcomes.
Study Design and Setting
The REMORA trial employs a non-commercial, superiority, stepped wedge cluster randomized controlled trial design. Participating hospital sites continually recruit patients, initially offering standard of care clinic visits and then switching to visits with integrated symptom tracking. The order in which sites switch is randomized, ensuring a rigorous evaluation of the intervention's impact. The trial involves 16 rheumatology outpatient departments providing secondary care for people with RA. To be eligible, sites must not already use integrated symptom tracking but have staff willing to discuss symptom data with patients during clinic visits and collect trial outcome data.
Intervention: Integrated Symptom Tracking
Patients allocated to the intervention group are prescribed integrated symptom tracking using the REMORA app on their smartphones. This app prompts patients to complete daily, weekly, and monthly question sets regarding their symptoms and other patient-reported aspects of living with RA. The app data is stored in a regional data repository and visualized in an interactive dashboard accessible to healthcare professionals within the patient's electronic health record system. Healthcare professionals receive training on using the dashboard to discern patterns of time-varying disease activity since the patient’s last clinic visit. The dashboard is intended to augment, not replace, verbal questions and history taking during clinical practice.
Control: Standard of Care
Patients in the control group receive clinic visits in accordance with usual clinical practice. Evaluation of the patient's condition since the last appointment is limited to verbal questions and history taking, as per standard of care. No tracked symptom data is available for review, and patients do not have access to the REMORA app.
Eligibility and Recruitment
Adult patients (18 years or older) under the care of a consented healthcare professional with active RA, regular access to an app-compatible mobile device, and the ability to follow intervention set-up instructions are eligible to participate. Healthcare professionals responsible for the assessment and treatment of people with RA, with access to the hospital’s electronic health record system, and willing to review the REMORA dashboard during clinical visits are also eligible.
Primary and Secondary Outcomes
The primary outcome is the difference in the marginal mean disease activity score (DAS) as measured on the DAS28 with C-reactive protein (DAS28-CRP) at 12 ± 3 months follow-up between the standard of care and the integrated symptom tracking groups, after accounting for covariates. Secondary outcomes include quality of life, shared decision-making, and cost-effectiveness.
Sample Size and Statistical Analysis
The trial aims to recruit a total of 736 participants (46 per site) to achieve an analysis sample size of 432, accounting for potential attrition. The primary analysis will use a generalized linear mixed-effects regression model, with DAS28-CRP at 12 ± 3-months follow-up as the outcome. The model will include DAS28-CRP at baseline, follow-up length, and intervention as predictors, with cluster as a random effect.
Patient and Public Involvement
Patient and public involvement and engagement (PPIE) has been integral to the REMORA program since its inception. A dedicated PPIE group consisting of nine members with lived experience of RA supports the current trial, informing the trial design and co-producing patient-facing materials.
Data Collection and Management
Data is collected through electronic questionnaires, electronic health record data extraction, paper case report forms, interactive dashboard usage data, and symptom completion data. Strict confidentiality measures are in place, with all personal data regarded as confidential and managed securely.
Expected Impact
The REMORA trial is poised to provide valuable insights into the effectiveness of integrating symptom tracking technology into routine RA care. By enhancing the information available to healthcare professionals during consultations, this intervention has the potential to improve disease management, patient outcomes, and the overall quality of care for individuals living with rheumatoid arthritis.
