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. 2020 Feb 19;9(2):e15105.
doi: 10.2196/15105.

A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial

Bart F Seppen  1   2 , Merel J L'ami  1 , Sharon Duarte Dos Santos Rico  1 , Marieke M Ter Wee  3 , Franktien Turkstra  1 , Leo D Roorda  4 , Fabio S Catarinella  5 , Dirkjan van Schaardenburg  1   6 , Michael T Nurmohamed  1   2 , Maarten Boers  1   3 , Wouter H Bos  1
Affiliations

A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial

Bart F Seppen et al. JMIR Res Protoc. .

Abstract

Background: Telemedicine based on self-measurement of disease activity could be one of the key components to create the health care system of the future. Previous publications in various medical fields have shown that it is possible to safely telemonitor patients while reducing the number of outpatient clinic visits. For this purpose, we developed a mobile phone app for patients with rheumatoid arthritis (RA), which allows them to self-monitor their disease.

Objective: The objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA.

Methods: This is a randomized controlled trial that will be performed for 1 year. A total of 176 patients with RA will be randomized to either self-initiated care with only one scheduled follow-up consultation assisted by our app or usual care. The coprimary outcome measures are the number of outpatient clinic consultations with a rheumatologist taking place during the trial period and the mean disease activity score as measured by the disease activity score 28 (DAS28) at 12 months. The secondary outcomes are patient satisfaction, adherence, patient empowerment, and cost evaluation of health care assisted by the app.

Results: Recruitment started in May 2019, and up to 18 months will be required for completion of recruitment. Thus far, 78 patients have been randomized, and thus far, experiences with the app have been positive. The study results are expected to be published by the end of 2021.

Conclusions: The completion of this study will provide important data regarding the following: (1) safety of self-initiated care supported by a smartphone app in terms of DAS28 and (2) efficacy of lowering health care usage with this new strategy of providing health care.

Trial registration: Netherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715.

International registered report identifier (irrid): DERR1-10.2196/15105.

Keywords: rheumatoid arthritis; smartphone app; telemonitoring.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: The software for the smartphone app is owned by Brightfish BV, and author FC is cofounder of Brightfish BV.

Figures

Figure 1
Figure 1
The design, test, and redesign approach in three distinct phases. In phase I, the app was developed and tested twice. A prepilot check (Ia) was performed to test usability. Subsequently, the app was tested in a mixed-methods pilot study (Ib). In phase II, further development was performed and the new app was re-evaluated with another mixed-methods pilot study (manuscript of pilot studies in preparation) [19].
Figure 2
Figure 2
The MijnReuma Reade App. Five separate screenshots illustrate the simple and comprehensive design and interface of the app. The second screenshot from the left portrays one of the disease activity graphs.
Figure 3
Figure 3
EMR dashboard. The EMR dashboard displays the results collected with the app. The data originate from the EMR itself, where they are stored in real-time after questionnaire completion in the app. The graph displays disease activity over time as measured by the RAPID3 (red) and DAS28 (blue). DAS28: Disease Activity Score 28; EMR: electronic medical record; RAPID3: Routine Assessment of Patient Index Data 3.
Figure 4
Figure 4
Flare algorithm. The app generates an alert with a link to self-management tips and advice to contact the outpatient clinic in case of an increased disease activity. Left: "Flare warning". Right: "Your disease appears to be more active".
Figure 5
Figure 5
Study design and outcomes over time. The control group continues regular care, usually with two or three preplanned outpatient clinic visits (OCVs) (light blue box). The intervention group has only one preplanned OCV (blue box) and monitors symptoms using a smartphone app. All patients complete five questionnaires during the study to compare secondary outcomes. CQR5: Compliance Questionnaire for Rheumatology 5; EC-17: Effective Consumer Scale 17; PEPPI-5: 5-item Perceived Efficacy in Patient-Physician Interactions; RAPID3: Routine Assessment of Patient Index Data 3; SUS: System Usability Scale; TiC-P: Treatment Inventory of Costs in Psychiatric Patients; TSQM-9: Treatment Satisfaction Questionnaire for Medication 9; WPAI: Work Productivity and Activity Impairment.
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