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 Show Affiliations »
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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. ©Bart F Seppen, Merel J L'ami, 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. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.02.2020.
RCT Entities: Population
Interventions
Outcomes
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. ©Bart F Seppen, Merel J L'ami, 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. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.02.2020.
Entities: Chemical
Disease
Gene
Species
Keywords:
rheumatoid arthritis; smartphone app; telemonitoring
Year: 2020
PMID： 32130182 DOI： 10.2196/15105
Source DB: PubMed Journal: JMIR Res Protoc ISSN： 1929-0748