OP0158-HPR Effectiveness of an e-health tailored self-management program for patients with rheumatoid arthritis: an explorative rct

Abstract

Background: E‐health programs have potential to support RA patients in selfmanagement. However, many of these programs are developed without involving patients. As a consequence, patient preferences for program use are not well known and these programs may not well suit patient's needs for self‐management support. We developed a tailored e‐health self‐management program for patients with RA with the help of a patient panel. While self‐management interventions are complex interventions, it is informative to perform an explorative RCT before embarking on a larger trial. Objectives: 1) Evaluate the potential effectiveness in patients with RA of a 12 month tailored e‐health self‐management program, versus 'usual care', on self‐management behaviour, self‐efficacy, general health status, focus on fatigue and the level of pain and fatigue; 2) exploration of floor and ceiling effects of the potential outcome measures at baseline and effect sizes at 6 and 12 months after baseline were used to identify outcome measures most likely to capture potential benefits Methods: The RCT was performed in out‐patients from two hospitals in the Netherlands. Inclusion criteria were RA patients 18 years or older, being able to speak and read Dutch and having access to internet. Patients were randomised to 'ehealth' in addition to 'usual care' or to 'usual care' alone. The 'e‐health' group received 12 months access to the online self‐management program. Assessment of outcomes 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), pain and fatigue (NRS scales). A linear mixed model for repeated measures, using the intention to treat principle was used to study differences between intervention and control groups. A sensitivity analysis was performed to study the influence of high and low compliance in the intervention group Results: In total 157 patients (n=78 intervention group versus n=79 control group) were included in the study. A statistically significant (p<0.05) betweengroup difference was only shown for the RAND‐36 vitality after 12 months, in favour of the 'e‐health' group. Effect sizes were low. Compared with the patients with non or low compliance, patients with a high compliance to the intervention scored statistically significant better on RAND‐36 perception after 12 months. Here also, effect sizes were low. Floor and ceiling effects were not apparent in the outcomes used. Conclusions: Based on these results it is not possible to conclude on possible positive effects of the intervention: for all outcomes the effect sizes were low. Consequently, it is not possible to select outcome measures to be regarded as primary/ main secondary outcomes for a larger trial. A process evaluation should be performed to give an explanation for the findings of this study.