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远程与面对面骨关节炎管理项目比较方案(COASTAL):一项随机实施试验

Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial.

作者信息

Yuan Shiwen, Bowden Jocelyn L, Eyles Jillian P, Duong Vicky, Messier Stephen, Losina Elena, Levesque Jean Frederic, Briggs Andrew M, Dowsey Michelle M, Deveza Leticia Alle, Rankin Nicole M, Barton Christian J, Dear Blake F, Pratt Carin, Smithers Jonathan, Hardy Louise, Bills Caroline, Thompson Julia, Buttel Tom, Ewald Daniel, Cheng Kevin, Ware Nicola, Richardson Daniel, Morgan Erica, Strelnikow Monique, Venkatesha Venkatesha, Warhurst Alexandra, Kurien Vineeta, Chery Scott, Hunter David J

机构信息

Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.

Department of Rheumatology, Guangzhou First People's Hospital, Guangzhou, Guangdong, China.

出版信息

Osteoarthr Cartil Open. 2025 Jul 8;7(3):100647. doi: 10.1016/j.ocarto.2025.100647. eCollection 2025 Sep.


DOI:10.1016/j.ocarto.2025.100647
PMID:40697621
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12281381/
Abstract

OBJECTIVE: To determine the comparative effectiveness of three evidence-informed approaches to delivering osteoarthritis (OA) care in real-world settings: face-to-face services, telehealth services or a mobile application (app). DESIGN: COASTAL (ACTRN12624000996561) comprises two aims: the primary aim is a three-arm, non-inferiority, comparative-effectiveness, type I hybrid implementation RCT; and the secondary aim is a superiority trial to compare the three interventions separately to an untreated, non-randomized control group. We will recruit 1348 participants (primary aim:1011 interventions; secondary aim:1011 interventions, 337 controls) with knee OA referred to a NSW public Osteoarthritis Chronic Care Program (OACCP). Eligible participants who consent to OACCP participation will be randomized 1:1:1 to receive care through the face-to-face OACCP, a telehealth service, or the "OA Coach" app, over 6-months. All participants will receive a standardized needs assessment; OA education; collaboratively developed, personalized management plan with a focus on therapeutic exercise, physical activity, pain management, and weight-management, according to each arm's mode of delivery. People who have declined OACCP participation will be eligible for the control group. The primary outcome is change in average knee pain during walking at 6-months (11-point NRS). Secondary, implementation, and economic evaluation outcomes will be collected at 6 and 12-months.The protocol was co-developed with people with knee OA, clinicians delivering the services, and other stakeholders. Ethical approval granted by the Northern Sydney Local Health District (2024/ETH01461). CONCLUSION: The results of this trial will provide critical evidence to help people with OA, clinicians, service planners and policymakers choose between different modes of delivering care for knee OA.

摘要

目的:确定在现实环境中提供骨关节炎(OA)护理的三种循证方法的比较效果:面对面服务、远程医疗服务或移动应用程序(应用)。 设计:COASTAL(ACTRN12624000996561)包括两个目标:主要目标是一项三臂、非劣效性、比较效果、I型混合实施随机对照试验;次要目标是一项优效性试验,将三种干预措施分别与未接受治疗的非随机对照组进行比较。我们将招募1348名患有膝骨关节炎且被转诊至新南威尔士州公共骨关节炎慢性护理项目(OACCP)的参与者(主要目标:1011例干预;次要目标:1011例干预,337例对照)。同意参与OACCP的符合条件的参与者将按1:1:1随机分组,在6个月内通过面对面的OACCP、远程医疗服务或“OA教练”应用程序接受护理。所有参与者将接受标准化需求评估;OA教育;根据各臂的提供方式,共同制定个性化管理计划,重点是治疗性锻炼、身体活动、疼痛管理和体重管理。拒绝参与OACCP的人将有资格进入对照组。主要结局是6个月时行走时平均膝关节疼痛的变化(11点数字评定量表)。次要、实施和经济评估结局将在6个月和12个月时收集。该方案是与膝骨关节炎患者、提供服务的临床医生和其他利益相关者共同制定的。获得了北悉尼地方卫生区的伦理批准(2024/ETH01461)。 结论:本试验的结果将提供关键证据,以帮助骨关节炎患者、临床医生、服务规划者和政策制定者在为膝骨关节炎提供护理的不同方式之间做出选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/64a7/12281381/57e27976a858/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/64a7/12281381/57e27976a858/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/64a7/12281381/57e27976a858/gr1.jpg

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[1]
Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial.

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本文引用的文献

[1]
General practitioners experience multi-level barriers to implementing recommended care for hip and knee osteoarthritis: a qualitative study.

BMC Prim Care. 2024-12-19

[2]
Effectiveness of Internet-Based Telehealth Programs in Patients With Hip or Knee Osteoarthritis: Systematic Review and Meta-Analysis.

J Med Internet Res. 2024-9-30

[3]
The OARSI Joint Effort Initiative: Priorities for osteoarthritis management program implementation and research 2024-2028.

Osteoarthr Cartil Open. 2023-9-16

[4]
Evaluation of a therapist-guided virtual psychological pain management program when provided as routine care: a prospective pragmatic cohort study.

Pain Med. 2023-12-1

[5]
Patient appropriateness for total knee arthroplasty and predicted probability of a good outcome.

RMD Open. 2023-4

[6]
Evaluating Osteoarthritis Management Programs: outcome domain recommendations from the OARSI Joint Effort Initiative.

Osteoarthritis Cartilage. 2023-7

[7]
The osteoarthritis knowledge scale.

Musculoskeletal Care. 2023-6

[8]
Understanding the management of osteoarthritis: A qualitative study of GPs and orthopaedic surgeons in Tasmania, Australia.

Osteoarthr Cartil Open. 2021-10-9

[9]
Effectiveness of a New Service Delivery Model for Management of Knee Osteoarthritis in Primary Care: A Cluster Randomized Controlled Trial.

Arthritis Care Res (Hoboken). 2023-6

[10]
Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial.

BMJ Open. 2020-11-3

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