Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA)
Abstract Background Rheumatoid arthritis (RA) considerably impacts patients’ lives. Patients’ confidence in their ability to manage this impact, or self-efficacy, can be supported with self-management interventions. One approach is to use mobile health (mHealth) applications, which can additionally...
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ftdoajarticles:oai:doaj.org/article:ef68c22b7a7849308b4159aa14e1ac72 2023-12-03T10:25:02+01:00 Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA) Michaël Doumen Elias De Meyst Cedric Lefevre Sofia Pazmino Johan Joly Delphine Bertrand Mieke Devinck René Westhovens Patrick Verschueren 2023-10-01T00:00:00Z https://doi.org/10.1186/s13063-023-07733-y https://doaj.org/article/ef68c22b7a7849308b4159aa14e1ac72 EN eng BMC https://doi.org/10.1186/s13063-023-07733-y https://doaj.org/toc/1745-6215 doi:10.1186/s13063-023-07733-y 1745-6215 https://doaj.org/article/ef68c22b7a7849308b4159aa14e1ac72 Trials, Vol 24, Iss 1, Pp 1-12 (2023) Rheumatoid arthritis Self-management Mobile health Mobile applications Telemedicine Patient-reported outcomes Medicine (General) R5-920 article 2023 ftdoajarticles https://doi.org/10.1186/s13063-023-07733-y 2023-11-05T01:44:05Z Abstract Background Rheumatoid arthritis (RA) considerably impacts patients’ lives. Patients’ confidence in their ability to manage this impact, or self-efficacy, can be supported with self-management interventions. One approach is to use mobile health (mHealth) applications, which can additionally provide insight into disease impact by remotely monitoring patient-reported outcomes. However, user engagement with mHealth-apps is variable, and concerns exist that remote monitoring might make patients overly attentive to symptoms. Methods App-based Education and GOal setting in RA (AEGORA) is a multicentre, pragmatic randomised controlled trial investigating an mHealth-based self-management intervention to improve self-efficacy and remotely monitor disease impact in patients with RA. The intervention is provided via an adapted version of the application Sidekick (Sidekick Health, Reykjavik, Iceland) and consists of education, goal setting, lifestyle advice, and remote assessment of the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. Across two centres, 120 patients will be recruited and randomised (2:1:1) to usual care or intervention group A/B (study app with weekly/monthly prompts to complete the RAID, respectively). Outcomes are assessed at baseline and after 4–6 months. The primary endpoint is a clinically important improvement (≥ 5.5/110) in the Arthritis Self-Efficacy Scale in the combined intervention group compared to usual care. Secondary endpoints are (a) non-inferiority regarding pain catastrophising, as a measure of symptom hypervigilance; (b) superiority regarding the RAID, sleep quality, and physical activity; and (c) participant engagement with the study app. Finally, the relationship between engagement, prompted frequency of RAID questionnaires, and the primary and secondary outcomes will be explored. Discussion The AEGORA trial aims to study the effectiveness of mHealth-based, multicomponent self-management support to improve self-efficacy in the context of RA, while providing ... Article in Journal/Newspaper Iceland Directory of Open Access Journals: DOAJ Articles Trials 24 1 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
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English |
topic |
Rheumatoid arthritis Self-management Mobile health Mobile applications Telemedicine Patient-reported outcomes Medicine (General) R5-920 |
spellingShingle |
Rheumatoid arthritis Self-management Mobile health Mobile applications Telemedicine Patient-reported outcomes Medicine (General) R5-920 Michaël Doumen Elias De Meyst Cedric Lefevre Sofia Pazmino Johan Joly Delphine Bertrand Mieke Devinck René Westhovens Patrick Verschueren Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA) |
topic_facet |
Rheumatoid arthritis Self-management Mobile health Mobile applications Telemedicine Patient-reported outcomes Medicine (General) R5-920 |
description |
Abstract Background Rheumatoid arthritis (RA) considerably impacts patients’ lives. Patients’ confidence in their ability to manage this impact, or self-efficacy, can be supported with self-management interventions. One approach is to use mobile health (mHealth) applications, which can additionally provide insight into disease impact by remotely monitoring patient-reported outcomes. However, user engagement with mHealth-apps is variable, and concerns exist that remote monitoring might make patients overly attentive to symptoms. Methods App-based Education and GOal setting in RA (AEGORA) is a multicentre, pragmatic randomised controlled trial investigating an mHealth-based self-management intervention to improve self-efficacy and remotely monitor disease impact in patients with RA. The intervention is provided via an adapted version of the application Sidekick (Sidekick Health, Reykjavik, Iceland) and consists of education, goal setting, lifestyle advice, and remote assessment of the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. Across two centres, 120 patients will be recruited and randomised (2:1:1) to usual care or intervention group A/B (study app with weekly/monthly prompts to complete the RAID, respectively). Outcomes are assessed at baseline and after 4–6 months. The primary endpoint is a clinically important improvement (≥ 5.5/110) in the Arthritis Self-Efficacy Scale in the combined intervention group compared to usual care. Secondary endpoints are (a) non-inferiority regarding pain catastrophising, as a measure of symptom hypervigilance; (b) superiority regarding the RAID, sleep quality, and physical activity; and (c) participant engagement with the study app. Finally, the relationship between engagement, prompted frequency of RAID questionnaires, and the primary and secondary outcomes will be explored. Discussion The AEGORA trial aims to study the effectiveness of mHealth-based, multicomponent self-management support to improve self-efficacy in the context of RA, while providing ... |
format |
Article in Journal/Newspaper |
author |
Michaël Doumen Elias De Meyst Cedric Lefevre Sofia Pazmino Johan Joly Delphine Bertrand Mieke Devinck René Westhovens Patrick Verschueren |
author_facet |
Michaël Doumen Elias De Meyst Cedric Lefevre Sofia Pazmino Johan Joly Delphine Bertrand Mieke Devinck René Westhovens Patrick Verschueren |
author_sort |
Michaël Doumen |
title |
Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA) |
title_short |
Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA) |
title_full |
Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA) |
title_fullStr |
Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA) |
title_full_unstemmed |
Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA) |
title_sort |
effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (aegora) |
publisher |
BMC |
publishDate |
2023 |
url |
https://doi.org/10.1186/s13063-023-07733-y https://doaj.org/article/ef68c22b7a7849308b4159aa14e1ac72 |
genre |
Iceland |
genre_facet |
Iceland |
op_source |
Trials, Vol 24, Iss 1, Pp 1-12 (2023) |
op_relation |
https://doi.org/10.1186/s13063-023-07733-y https://doaj.org/toc/1745-6215 doi:10.1186/s13063-023-07733-y 1745-6215 https://doaj.org/article/ef68c22b7a7849308b4159aa14e1ac72 |
op_doi |
https://doi.org/10.1186/s13063-023-07733-y |
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Trials |
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24 |
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1 |
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1784273677321240576 |