Effectiveness of an online self-management tool, OPERAS (an On-demand Program to EmpoweR Active Self-management), for people with rheumatoid arthritis: a research protocol

Abstract Background. Active self-management is a process where patients are fully engaged in managing their health in daily life by having access to contextualized health data and tailored guidance to support a healthy lifestyle. The current study aims to determine whether an e-health intervention which incorporates symptom/disease activity monitoring and physical activity counselling can improve self-management ability in patients with rheumatoid arthritis (RA). Methods. The Empowering active self-management of arthritis: Raising the bar with OPERAS (an On-demand Program to EmpoweR Active Self-management) project is a randomized controlled trial which uses a delayed control design. 134 participants with RA will be randomized to either start the intervention immediately (Immediate Group) or start 6 months later (Delayed Group). The intervention involves: 1) use of a Fitbit-compatible web app to record and monitor their RA disease activity, symptoms and time spent on physical activity and a Fitbit; 2) group education and individual counselling by a physiotherapist (PT), and 3) 6 phone calls with a PT. The primary outcome measure is self-management ability measured by the Patient Activation Measure. Secondary outcome measures include disease status, fatigue, pain, depressive symptoms, and characteristics of habitual behavior. In addition, time spent in physical activity and sedentary activity with a wearable multi-sensor device (SenseWear Mini). Following the 6-month intervention, we will interview a sample of participants to examine their experiences with the intervention. Discussion. The results of this study will help to determine whether this technology-enhanced self-management intervention improves self-management ability and their health outcomes for people living with RA. A limitation of this study is that participants will need to self-report their symptoms, disease status, and treatment use through questionnaires on the OPERAS web app. The user-friendly interface, reminder emails from the research staff, and tailored guidance from PTs will encourage participants to actively engage with the app. Trial Registration. Date of last update in ClinicalTrials.gov: January 2, 2019 ClinicalTrials.gov Identifier: NCT03404245