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...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07733-y |
| _version_ | 1827781115305263104 |
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| 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 |
| collection | DOAJ |
| 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 potentially valuable insights into temporal disease activity dynamics and the feasibility and possible negative effects of remote symptom monitoring in this population. Trial registration Clinicaltrials.gov NCT05888181. Retrospectively registered on March 23, 2023. Study inclusion started on March 3, 2023. |
| first_indexed | 2024-03-11T15:13:13Z |
| format | Article |
| id | doaj.art-ef68c22b7a7849308b4159aa14e1ac72 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-11T15:13:13Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ef68c22b7a7849308b4159aa14e1ac722023-10-29T12:35:49ZengBMCTrials1745-62152023-10-0124111210.1186/s13063-023-07733-yEffectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA)Michaël Doumen0Elias De Meyst1Cedric Lefevre2Sofia Pazmino3Johan Joly4Delphine Bertrand5Mieke Devinck6René Westhovens7Patrick Verschueren8Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU LeuvenDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU LeuvenRheumatology, University Hospitals LeuvenDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU LeuvenRheumatology, University Hospitals LeuvenDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU LeuvenRheumatology, AZ Sint-LucasDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU LeuvenDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU LeuvenAbstract 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 potentially valuable insights into temporal disease activity dynamics and the feasibility and possible negative effects of remote symptom monitoring in this population. Trial registration Clinicaltrials.gov NCT05888181. Retrospectively registered on March 23, 2023. Study inclusion started on March 3, 2023.https://doi.org/10.1186/s13063-023-07733-yRheumatoid arthritisSelf-managementMobile healthMobile applicationsTelemedicinePatient-reported outcomes |
| spellingShingle | 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) Trials Rheumatoid arthritis Self-management Mobile health Mobile applications Telemedicine Patient-reported outcomes |
| 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_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_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_sort | effectiveness and feasibility of a mobile health self management intervention in rheumatoid arthritis study protocol for a pragmatic multicentre randomised controlled trial aegora |
| topic | Rheumatoid arthritis Self-management Mobile health Mobile applications Telemedicine Patient-reported outcomes |
| url | https://doi.org/10.1186/s13063-023-07733-y |
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