A multidisciplinary, cross-sectorial management program for people living with hand osteoarthritis (HANDY): protocol for a feasibility study.

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
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.

手骨关节炎患者多学科、跨部门管理方案(HANDY):可行性研究方案。
背景:手骨关节炎(HOA)患者在进行日常生活活动(ADL)时遇到困难。尽管国际治疗建议支持非药物干预,但职业治疗的转诊很少。HANDY是一个针对HOA患者的多学科跨部门管理项目,包括由全科医生(gp)执行的需求评估和职业治疗转诊程序,以及在市政康复机构提供的以团体为基础的职业治疗干预。本研究旨在评估HANDY程序的第一个版本(HANDY 1.0)的可行性。方法:将在两个城市和相关的一般做法中进行可行性研究,以评估HANDY计划的内容和实施方面。根据国际可行性评估指南,评估的方面包括:干预措施的发展、干预措施的组成部分、感知价值、益处、危害或意外后果、原则上的可接受性、实践中的可行性和可接受性、保真度、可及范围和剂量。参与者将从访问全科医生时患有HOA的人、全科医生本人和市政康复机构雇用的职业治疗临床医生中招募。每个城市将提供两次以小组为基础的职业治疗干预,每次涉及多达8名患有HOA的参与者。定性和定量数据将根据登记表、日志、ADL能力评估和定性访谈收集。结论:本研究将首次探讨多学科、跨部门管理项目HANDY对HOA患者的内容和实施的可行性。这将使我们能够决定是否进行一项试点随机对照试验,评估与试验设计、实施和过程相关的方面。试验注册:Clinicaltrials.gov PRS注册,注册号NCT06254105。注册于2024年1月22日-追溯注册,https://clinicaltrials.gov/study/NCT06254105。预计研究完成日期为2024年6月28日。然而,在提交本文件时,参与者的后续行动仍在进行中。
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
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.
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