Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial.
Anne Therese Tveter, Kristine Aasness Fjeldstad, Cecilie Varsi, Marit Kristin Maarnes, Stein Jarle Pedersen, Barbara S Christensen, Thalita Blanck, Sissel B Nyheim, Yeliz Prior, Mathilda Björk, Tim Pelle, Ingvild Kjeken
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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).
期刊介绍：
RHEUMATOLOGY INTERNATIONAL is an independent journal reflecting world-wide progress in the research, diagnosis and treatment of the various rheumatic diseases. It is designed to serve researchers and clinicians in the field of rheumatology.
RHEUMATOLOGY INTERNATIONAL will cover all modern trends in clinical research as well as in the management of rheumatic diseases. Special emphasis will be given to public health issues related to rheumatic diseases, applying rheumatology research to clinical practice, epidemiology of rheumatic diseases, diagnostic tests for rheumatic diseases, patient reported outcomes (PROs) in rheumatology and evidence on education of rheumatology. Contributions to these topics will appear in the form of original publications, short communications, editorials, and reviews. "Letters to the editor" will be welcome as an enhancement to discussion. Basic science research, including in vitro or animal studies, is discouraged to submit, as we will only review studies on humans with an epidemological or clinical perspective. Case reports without a proper review of the literatura (Case-based Reviews) will not be published. Every effort will be made to ensure speed of publication while maintaining a high standard of contents and production.
Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1964 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted.
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