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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

Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial Thumbnail


Authors

Anne Therese Tveter

Kristine Aasness Fjeldstad

Cecilie Varsi

Marit Kristin Maarnes

Stein Jarle Pedersen

Barbara S. Christensen

Thalita Blanck

Sissel B. Nyheim

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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