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

Overview

Journal JMIR Res Protoc

Publisher JMIR Publications

Specialty General Medicine

Date 2020 Mar 5

PMID 32130182

Citations 13

Authors

Bart F Seppen

Merel J lAmi

Sharon Duarte Dos Santos Rico

Marieke M Ter Wee

Franktien Turkstra

Leo D Roorda

Fabio S Catarinella

Dirkjan van Schaardenburg

Michael T Nurmohamed

Maarten Boers

Wouter H Bos

Affiliations

Soon will be listed here.

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.

Citing Articles

Self-monitoring combined with patient-initiated care in RA patients with low disease activity: cost-effectiveness analysis of an RCT.

Seppen B, Greuter M, Wiegel J, Ter Wee M, Boers M, Nurmohamed M Rheumatology (Oxford). 2023; 62(10):3366-3372.

PMID: 36799560 PMC: 10547523. DOI: 10.1093/rheumatology/kead084.

Who stop telemonitoring disease activity and who adhere: a prospective cohort study of patients with inflammatory arthritis.

Wiegel J, Seppen B, Nurmohamed M, Bos W, ter Wee M BMC Rheumatol. 2022; 6(1):73.

PMID: 36447263 PMC: 9708135. DOI: 10.1186/s41927-022-00303-w.

Digitally supported shared decision-making and treat-to-target in rheumatology: a qualitative study embedded in a multicenter randomized controlled trial.

Muehlensiepen F, May S, Hadaschik K, Vuillerme N, Heinze M, Grahammer M Rheumatol Int. 2022; 43(4):695-703.

PMID: 36229671 PMC: 9995411. DOI: 10.1007/s00296-022-05224-y.

Development and Testing of an Electronic Health Record-Integrated Patient-Reported Outcome Application and Intervention to Improve Efficiency of Rheumatoid Arthritis Care.

Solomon D, Dalal A, Landman A, Santacroce L, Altwies H, Stratton J ACR Open Rheumatol. 2022; 4(11):964-973.

PMID: 36099161 PMC: 9661861. DOI: 10.1002/acr2.11498.

Smartphone-Assisted Patient-Initiated Care Versus Usual Care in Patients With Rheumatoid Arthritis and Low Disease Activity: A Randomized Controlled Trial.

Seppen B, Wiegel J, Ter Wee M, van Schaardenburg D, Roorda L, Nurmohamed M Arthritis Rheumatol. 2022; 74(11):1737-1745.

PMID: 35818342 PMC: 9826407. DOI: 10.1002/art.42292.

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