A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial
BackgroundTelemedicine 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 outpatien...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2020-02-01
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| Series: | JMIR Research Protocols |
| Online Access: | http://www.researchprotocols.org/2020/2/e15105/ |
| _version_ | 1819278963729498112 |
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| author | Seppen, Bart F L'ami, Merel J Duarte dos Santos Rico, Sharon ter Wee, Marieke M Turkstra, Franktien Roorda, Leo D Catarinella, Fabio S van Schaardenburg, Dirkjan Nurmohamed, Michael T Boers, Maarten Bos, Wouter H |
| author_facet | Seppen, Bart F L'ami, Merel J Duarte dos Santos Rico, Sharon ter Wee, Marieke M Turkstra, Franktien Roorda, Leo D Catarinella, Fabio S van Schaardenburg, Dirkjan Nurmohamed, Michael T Boers, Maarten Bos, Wouter H |
| author_sort | Seppen, Bart F |
| collection | DOAJ |
| description | BackgroundTelemedicine 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.
ObjectiveThe objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA.
MethodsThis 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.
ResultsRecruitment 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.
ConclusionsThe 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 RegistrationNetherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715
International Registered Report Identifier (IRRID)DERR1-10.2196/15105 |
| first_indexed | 2024-12-24T00:20:22Z |
| format | Article |
| id | doaj.art-c6997801d2554c7bacf33639ea960114 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-12-24T00:20:22Z |
| publishDate | 2020-02-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-c6997801d2554c7bacf33639ea9601142022-12-21T17:24:37ZengJMIR PublicationsJMIR Research Protocols1929-07482020-02-0192e1510510.2196/15105A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled TrialSeppen, Bart FL'ami, Merel JDuarte dos Santos Rico, Sharonter Wee, Marieke MTurkstra, FranktienRoorda, Leo DCatarinella, Fabio Svan Schaardenburg, DirkjanNurmohamed, Michael TBoers, MaartenBos, Wouter HBackgroundTelemedicine 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. ObjectiveThe objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA. MethodsThis 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. ResultsRecruitment 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. ConclusionsThe 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 RegistrationNetherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715 International Registered Report Identifier (IRRID)DERR1-10.2196/15105http://www.researchprotocols.org/2020/2/e15105/ |
| spellingShingle | Seppen, Bart F L'ami, Merel J Duarte dos Santos Rico, Sharon ter Wee, Marieke M Turkstra, Franktien Roorda, Leo D Catarinella, Fabio S van Schaardenburg, Dirkjan Nurmohamed, Michael T Boers, Maarten Bos, Wouter H A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial JMIR Research Protocols |
| title | A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial |
| title_full | A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial |
| title_fullStr | A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial |
| title_short | A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial |
| title_sort | smartphone app for self monitoring of rheumatoid arthritis disease activity to assist patient initiated care protocol for a randomized controlled trial |
| url | http://www.researchprotocols.org/2020/2/e15105/ |
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