Ulla Andersen, Vita Hagelskjær, Cecilie von Bülow, Henrik Gudbergsen, Henning Bliddal, Anna Døssing, Eva Ejlersen Wæhrens
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引用次数: 0
Abstract
Background: People with hand osteoarthritis (HOA) experience difficulties performing activities of daily living (ADL). Referral for occupational therapy is rare despite support for non-pharmacological interventions by international treatment recommendations. HANDY, a multidisciplinary cross-sectorial management program for people with HOA, includes procedures for needs evaluation and referral for occupational therapy performed by general practitioners (GPs) as well as a group-based occupational therapy intervention delivered in municipal rehabilitation settings. The present study aimed to evaluate the feasibility of this first version of the HANDY program (HANDY 1.0).
Methods: A feasibility study will be conducted in two municipalities and related general practices to evaluate aspects of the content and delivery of the HANDY program. In accordance with international guidelines for evaluation of feasibility, the aspects evaluated include: intervention development, intervention components, perceived values, benefits, harms or unintended consequences, acceptability in principle, feasibility and acceptability in practice, and fidelity, reach, and dose. Participants will be recruited among people with HOA when visiting their GP, GPs themselves, and occupational therapy clinicians employed in municipal rehabilitation settings. Each municipality will offer the group-based occupational therapy intervention twice, each time involving up to eight participants with HOA. Qualitative and quantitative data will be collected based on registration forms, logbooks, assessments of ADL ability, and qualitative interviews.
Conclusions: This study will be the first to examine the feasibility of the content and delivery of the multidisciplinary, cross-sectorial management program HANDY for people living with HOA. It will enable us to determine whether to proceed to a pilot randomized controlled trial evaluating aspects related to trial design, conduct, and processes.
Trial registration: Clinicaltrials.gov PRS registry, registration number NCT06254105. Registered 22nd January 2024-retrospectively registered, https://clinicaltrials.gov/study/NCT06254105 . Estimated date of study completion was 28th June 2024. However, participant follow-up is still ongoing at the time of submission of the present paper.
期刊介绍:
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.