Efficacy of a Web-Based Self-Management Enhancing Program for Patients with Rheumatoid Arthritis: Explorative Randomized Controlled Trial

Abstract

Background: Web-based self-management enhancing programs have the potential to support patients with rheumatoid arthritis(RA) in their self-management; for example, improve their health status by increasing their self-efficacy or taking their prescribedmedication. We developed a Web-based self-management enhancing program in collaboration with RA patients and professionalsas co-designers on the basis of the intervention mapping framework. Although self-management programs are complex interventions,it is informative to perform an explorative randomized controlled trial (RCT) before embarking on a larger trial.Objective: This study aimed to evaluate the efficacy of a Web-based self-management enhancing program for patients withRA and identify outcome measures most likely to capture potential benefits.Methods: A multicenter exploratory RCT was performed with an intervention group and a control group. Both groups receivedcare as usual. In addition, the intervention group received 12 months of access to a Web-based self-management program.Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included self-management behavior (PatientActivation Measurement, Self-Management Ability Scale), self-efficacy (Rheumatoid Arthritis task-specific Self-Efficacy,Perceived Efficacy in Patient-Physician Interaction), general health status (RAND-36), focus on fatigue (Modified Pain CopingInventory for Fatigue), and perceived pain and fatigue (Numeric Rating 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: No positive effects were found regarding the outcome measurements. Effect sizes were low.Conclusions: Based on these results, it is not possible to conclude on the positive effects of the intervention or to select outcomemeasures to be regarded as the primary/main or secondary outcomes for a future trial. A process evaluation should be performedto provide more insight into the low compliance with and effectiveness of the intervention. This can determine for whom thissort of program will work and help to fine-tune the inclusion criteria.