Journal Article

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

Björk, Mathilda, Blanck, Thalita, Nyheim, Sissel B., Kjeken, Ingvild, Varsi, Cecilie, Tveter, Anne Therese, Christensen, Barbara S., Maarnes, Marit Kristin, Prior, Yeliz, Pelle, Tim, Pedersen, Stein Jarle, Fjeldstad, Kristine Aasness

2025

Overview

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).

• Publisher: Springer Berlin Heidelberg,Springer Nature B.V
• Subject: Cost-Benefit Analysis / Female / Hand Joints - physiopathology / Hand Strength / Hands / Humans / Male / Medicine / Medicine & Public Health / Middle Aged / Mobile Applications / Multicenter Studies as Topic / Norway / Osteoarthritis / Osteoarthritis - physiopathology / Osteoarthritis - therapy / Protocols / Quality of Life / Randomized Controlled Trials as Topic / Rheumatology / Self-Management - methods / Treatment Outcome