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

Zuidema, R., Dulmen, S. van, Nijhuis-van der Sanden M., Meek, I., Ende, C. van den, Fransen, J., Gaal, B. van. Efficacy of an online self-management enhancing programme for patients with rheumatoid arthritis: an explorative RCT Journal of Medical Internet Research: 2019, 21(4), e12463
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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.