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

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).