Efficacy of an online self-management enhancing programme for patients with rheumatoid arthritis: an explorative RCT

Background: Online self-management enhancing programmes has the potential to support patients with Rheumatoid Arthritis in their self-management, for example improve their health status and self-efficacy or decrease overuse of medication. We developed an online self-management enhancing program in collaboration with RA patients and professionals as co-designers, based on the Intervention Mapping Framework. While self-management programs are complex interventions, it is informative to perform an explorative Randomized Controlled Trial before embarking on a larger trial. Objective: This study aimed to evaluate the efficacy of an online self-management enhancing programme for patients with rheumatoid arthritis and to identify outcome measures most likely to capture potential benefits. Methods: A multicentre exploratory randomised controlled trial was performed with an intervention and a control group. Both groups received care as usual. In addition, the intervention group received 12 months of access to an online self-management programme. Assessment occurred at baseline, 6 and 12 months. Outcome measures included self-management behaviour (PAM-13, SMAS-S), self-efficacy (RASE, PEPPI-5), general health status (RAND-36), focus on fatigue (MPCI-F), perceived pain and fatigue (NRS scales). A linear mixed model for repeated measures, using the intention-to-treat principle, was applied to study differences between the patients in the intervention (n=78) and control (n=79) groups. A sensitivity analysis was performed in the intervention group to study the influence of patients with high (N=30) and low (N=40) use of the intervention. Results: The intervention group scored statistically significantly better on the subscale RAND-36 vitality. The group with high use scored statistically significantly better on the subscale RAND-36 perception, although the effect sizes were small. No other statistically significant or clinically relevant effects were found. Conclusions: Based on these results, it is not possible to conclude on the positive effects of the intervention or to select outcome measures to be regarded as the primary/main or secondary outcomes for a future trial. A process evaluation should be performed to provide more insight into the low compliance with and effectiveness of the intervention. (aut. ref.)