Evidence map›Paper›PMID 37898781›Full record

ArticleTrials2023

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05888181 (Effectiveness and Feasibility of a Mobile Health Self-management Intervention for Patients With Rheumatoid Arthritis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05888181 nacompletednot on this map

Effectiveness and Feasibility of a Mobile Health Self-management Intervention for Patients With Rheumatoid Arthritis: the App-based Education and GOal-setting in Rheumatoid Arthritis Trial

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2023 to 2024Enrolled128ConditionsRheumatoid ArthritisArmsMobile app-based self-management intervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Michaël DoumenDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium. michael.doumen@kuleuven.be.ORCID http://orcid.org/0000-0001-6073-7635
Elias De MeystDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium.
Cedric LefevreRheumatology, University Hospitals Leuven, Leuven, Belgium.
Sofia PazminoDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium.
Johan JolyRheumatology, University Hospitals Leuven, Leuven, Belgium.
Delphine BertrandDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium.
Mieke DevinckRheumatology, AZ Sint-Lucas, Bruges, Belgium.
René WesthovensDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium.
Patrick VerschuerenDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium.
KU Leuven · BEAZ Sint-Lucas · BE

Funding

Fonds Wetenschappelijk Onderzoek 1S85521N
6 · The paper itself

Abstract

backgroundRheumatoid 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.

methodsApp-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 registrationClinicaltrials.gov NCT05888181. Retrospectively registered on March 23, 2023. Study inclusion started on March 3, 2023.

Indexed as

Arthritis, RheumatoidMobile ApplicationsSelf-ManagementTelemedicineFeasibility StudiesHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSurveys and QuestionnairesMobile applicationsMobile healthPatient-reported outcomesRandomised controlled trialRheumatoid arthritisSelf-managementTelemedicine

Identifiers

PMID37898781
PMCPMC10613379
OpenAlexW4388000303

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.