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一项针对手部骨关节炎患者的多学科、跨部门管理计划(HANDY):可行性研究方案

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

作者信息

Andersen Ulla, Hagelskjær Vita, von Bülow Cecilie, Gudbergsen Henrik, Bliddal Henning, Døssing Anna, Wæhrens Eva Ejlersen

机构信息

Occupation-Centred Occupational Therapy, The Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Frederiksberg, Denmark.

User Perspectives and Community-Based Interventions, Department of Public Health, University of Southern Denmark, Odense, Denmark.

出版信息

Pilot Feasibility Stud. 2025 May 15;11(1):68. doi: 10.1186/s40814-025-01653-1.

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.

摘要

背景

手部骨关节炎(HOA)患者在进行日常生活活动(ADL)时会遇到困难。尽管国际治疗建议支持非药物干预,但职业治疗转诊却很少见。HANDY是一项针对HOA患者的多学科跨部门管理计划,包括需求评估程序以及由全科医生(GP)进行的职业治疗转诊,以及在市政康复机构提供的基于小组的职业治疗干预。本研究旨在评估HANDY计划第一版(HANDY 1.0)的可行性。

方法

将在两个市政当局及相关全科诊所进行一项可行性研究,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:干预措施的制定、干预组成部分、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,以及保真度、覆盖范围和剂量。参与者将从就诊于全科医生的HOA患者、全科医生本人以及市政康复机构雇佣的职业治疗临床医生中招募。每个市政当局将提供两次基于小组的职业治疗干预,每次最多涉及八名HOA患者。将基于登记表、日志、ADL能力评估和定性访谈收集定性和定量数据。

结论

本研究将首次检验针对HOA患者的多学科跨部门管理计划HANDY的内容和实施的可行性。这将使我们能够确定是否继续进行一项试点随机对照试验,评估与试验设计、实施和流程相关的方面。

试验注册

Clinicaltrials.gov PRS注册库,注册号NCT06254105。2024年1月22日注册——追溯注册,https://clinicaltrials.gov/study/NCT06254105 。预计研究完成日期为2×4年6月28日。然而,在提交本文时,参与者的随访仍在进行中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5b7/12079999/e22f04aa68db/40814_2025_1653_Fig1_HTML.jpg

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