Development and Evaluation of a Smartphone Application for Self-Monitoring of Rheumatoid Arthritis Disease Activity: Results of Two Pilot Studies and Design of a Randomized Controlled Trial (Preprint)

BACKGROUND Rising health care costs, an increasing elderly population and shortage of (medical) personnel force us to think about alternative ways to organize our health care system. Telemedicine, based on self-measurement of disease activity, could be one of the key ingredients to create the health care system of the future. Previous publications in various fields have shown that it is possible to safely telemonitor patients whilst reducing the number of outpatient clinic visits. However, evidence for patients with RA is lacking. OBJECTIVE (1) To provide an extensive description of the development and evaluation of a smartphone application (app) for self-monitoring of rheumatoid arthritis (RA) disease activity. (2) To present the study design in order to measure the safety and efficacy of self-initiated care supported with an app. METHODS Following the Medical Research Council (MRC) guidance for developing and evaluating complex interventions, the development and evaluation of the app was carried out in three distinct phases. In the first phase design requirements were set by a team of patient representatives, health care professionals and software developers, the prototype app was developed and tested in a first pilot study. The second phase consisted of building a digital care platform, through which the app was integrated with the electronic medical record, other app-improvements and a second pilot study. The third phase comprises further improvements to achieve the set design requirements and a randomized controlled trial to evaluate the efficacy of self-management supported by the developed smartphone tool. RESULTS Two pilot studies evaluated the patient satisfaction, usability and adherence to the app. The studies were performed with 42 and 24 RA patients. In the initial pilot, the app was graded with an overall score of 8.0 (IQR 7.0-9.0). The mean system usability score was 76 (SD 15) and adherence was 60%. Consequently, improvements were made, integration to the EMR was completed and the second pilot showed similar (promising) results in terms of patient satisfaction, usability and adherence. In the planned assessor blind-pragmatic randomized controlled trial, 176 RA will be randomized to self-initiated care assisted by the app with only one scheduled follow-up consultation or to usual care. The co-primary outcome measures are the number of outpatient clinic consultations with a rheumatologist that took place during the 12 months trial period and the mean disease activity score as measured by the disease activity score 28 (DAS 28) at 12 months. Secondary outcomes include patient and physician satisfaction with care, patient empowerment, patient-physician interaction and therapeutic adherence. CONCLUSIONS We have developed an app that RA patients find satisfactory and usable for self-monitoring of disease activity. If proven safe and effective with the planned randomized controlled trial, our aim is to implement this telemonitoring strategy in the Dutch health care system. CLINICALTRIAL Trial ID: NL7715 (https://www.trialregister.nl/trial/7715)