Anne Therese Tveter
Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial
Therese Tveter, Anne; Aasness Fjeldstad, Kristine; Varsi, Cecilie; Kristin Maarnes, Marit; Jarle Pedersen, Stein; S. Christensen, Barbara; Blanck, Thalita; B. Nyheim, Sissel; Prior, Yeliz; Björk, Mathilda; Pelle, Tim; Kjeken, Ingvild
Authors
Kristine Aasness Fjeldstad
Cecilie Varsi
Marit Kristin Maarnes
Stein Jarle Pedersen
Barbara S. Christensen
Thalita Blanck
Sissel B. Nyheim
Prof Yeliz Prior Y.Prior@salford.ac.uk
Professor of Clinical Rehabilitation
Mathilda Björk
Tim Pelle
Ingvild Kjeken
Abstract
Objective: This protocol paper describes the rationale and design of a randomised controlled trial (RCT) that aims to evaluate the (cost-)effectiveness of a 12 week e-self-management intervention (Happy Hands app) in people with hand osteoarthritis (HOA).
Methods: In this multicentre RCT, 376 people with HOA will be recruited from all four health regions in Norway. Consenting participants will be randomly allocated to either a control group receiving usual care or an intervention group receiving the Happy Hands app in addition to usual care. Primary outcome will be measured at 3-months follow-up as the proportion of participants classified as OMERACT-OARSI responders (a composite score comprising change in pain, function, and disease activity), analysed using logistic regression. Secondary outcomes, including pain, hand function, stiffness, quality-of-care, health-related quality-of-life, grip strength, adherence and healthcare costs will be measured at 3- and 6-months follow-up.
Results: Recruitment was initiated in November 2022 with a total of 386 participants recruited by August 2023, 194 in the intervention group and 192 in the control group. Data collection was completed in February 2024.
Discussion: To our knowledge, this is one of the first large-scale, multicentre RCTs assessing the (cost-)effectiveness of a self-management program delivered through a smartphone app for people with HOA. The results from this trial can enhance our understanding of the role technology can play in managing HOA.
Trial registration: NCT05568875 (https://clinicaltrials.gov/study/NCT05568875, pre-registered October 3, 2022).
Journal Article Type | Article |
---|---|
Acceptance Date | Jan 5, 2025 |
Online Publication Date | Jan 16, 2025 |
Publication Date | Jan 16, 2025 |
Deposit Date | Feb 5, 2025 |
Publicly Available Date | Feb 5, 2025 |
Journal | Rheumatology International |
Print ISSN | 0172-8172 |
Electronic ISSN | 1437-160X |
Publisher | Springer Verlag |
Peer Reviewed | Peer Reviewed |
Volume | 45 |
Article Number | 30 |
DOI | https://doi.org/10.1007/s00296-025-05787-6 |
Keywords | Smartphone app, Hand exercises, EHealth, MHealth, Hand osteoarthritis, Randomized controlled trial |
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http://creativecommons.org/licenses/by/4.0/
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