Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial
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 a...
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Elsevier
2025-09-01
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Series: | Osteoarthritis and Cartilage Open |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S2665913125000834 |
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author | Shiwen Yuan Jocelyn L. Bowden Jillian P. Eyles Vicky Duong Stephen Messier Elena Losina Jean Frederic Levesque Andrew M. Briggs Michelle M. Dowsey Leticia Alle Deveza Nicole M. Rankin Christian J. Barton Blake F. Dear Carin Pratt Jonathan Smithers Louise Hardy Caroline Bills Julia Thompson Tom Buttel Daniel Ewald Kevin Cheng Nicola Ware Daniel Richardson Erica Morgan Monique Strelnikow Venkatesha Venkatesha Alexandra Warhurst Vineeta Kurien Scott Chery David J. Hunter |
author_facet | Shiwen Yuan Jocelyn L. Bowden Jillian P. Eyles Vicky Duong Stephen Messier Elena Losina Jean Frederic Levesque Andrew M. Briggs Michelle M. Dowsey Leticia Alle Deveza Nicole M. Rankin Christian J. Barton Blake F. Dear Carin Pratt Jonathan Smithers Louise Hardy Caroline Bills Julia Thompson Tom Buttel Daniel Ewald Kevin Cheng Nicola Ware Daniel Richardson Erica Morgan Monique Strelnikow Venkatesha Venkatesha Alexandra Warhurst Vineeta Kurien Scott Chery David J. Hunter |
author_sort | Shiwen Yuan |
collection | DOAJ |
description | 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. |
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spelling | doaj-art-6b826bfd16f94904ab692b0b4b67b51a2025-07-16T04:56:22ZengElsevierOsteoarthritis and Cartilage Open2665-91312025-09-0173100647Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trialShiwen Yuan0Jocelyn L. Bowden1Jillian P. Eyles2Vicky Duong3Stephen Messier4Elena Losina5Jean Frederic Levesque6Andrew M. Briggs7Michelle M. Dowsey8Leticia Alle Deveza9Nicole M. Rankin10Christian J. Barton11Blake F. Dear12Carin Pratt13Jonathan Smithers14Louise Hardy15Caroline Bills16Julia Thompson17Tom Buttel18Daniel Ewald19Kevin Cheng20Nicola Ware21Daniel Richardson22Erica Morgan23Monique Strelnikow24Venkatesha Venkatesha25Alexandra Warhurst26Vineeta Kurien27Scott Chery28David J. Hunter29Sydney 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, ChinaSydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia; Corresponding author. Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, Australia.Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, AustraliaSydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, AustraliaWake Forest University, Winston-Salem, North Carolina, USABrigham and Women's Hospital and Harvard Medical School, Boston, MA, USANSW Agency for Clinical Innovation, Sydney, NSW, AustraliaCurtin School of Allied Health, Curtin University, Perth, WA, AustraliaUniversity of Melbourne Department of Surgery, St. Vincent's Hospital, Fitzroy, VIC, AustraliaSydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, AustraliaMelbourne School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, VIC, AustraliaDepartment of Physiotherapy, Podiatry and Prosthetics and Orthotics, School of Allied Health Human Services and Sport, La Trobe University, Melbourne, VIC, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health Human Services and Sport, La Trobe University, Melbourne, VIC, AustraliaSchool of Psychological Sciences, Macquarie University, Sydney, NSW, AustraliaNorthern Sydney Local Health District, Royal North Shore Hospital, Sydney, NSW, AustraliaArthritis Australia, Sydney, NSW, AustraliaArthritis Australia, Sydney, NSW, AustraliaHealthChange Associates, Melbourne, Vic, AustraliaNSW Agency for Clinical Innovation, Sydney, NSW, AustraliaConsumer Investigator, Sydney, NSW, AustraliaUniversity Centre for Rural Health School of Medicine, University of Sydney, Sydney, NSW, AustraliaOsana, Sydney, NSW, AustraliaRamsay Health Research Foundation, Sydney, NSW, AustraliaNorthern Sydney Local Health District, Hornsby Hospital, Sydney, NSW, AustraliaSouth Eastern Sydney Local Health District, The Sutherland Hospital, Sydney, NSW, AustraliaSouthern NSW Local Health District, South East Regional Hospital. Bega, NSW, AustraliaNorthern Sydney Local Health District, Royal North Shore Hospital, Sydney, NSW, AustraliaRemedy Healthcare, Melbourne, VIC, AustraliaSydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, AustraliaSydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, AustraliaSydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, NSW, AustraliaObjective: 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.http://www.sciencedirect.com/science/article/pii/S2665913125000834OsteoarthritisKneeImplementationRandomized controlled trialManagement programs |
spellingShingle | Shiwen Yuan Jocelyn L. Bowden Jillian P. Eyles Vicky Duong Stephen Messier Elena Losina Jean Frederic Levesque Andrew M. Briggs Michelle M. Dowsey Leticia Alle Deveza Nicole M. Rankin Christian J. Barton Blake F. Dear Carin Pratt Jonathan Smithers Louise Hardy Caroline Bills Julia Thompson Tom Buttel Daniel Ewald Kevin Cheng Nicola Ware Daniel Richardson Erica Morgan Monique Strelnikow Venkatesha Venkatesha Alexandra Warhurst Vineeta Kurien Scott Chery David J. Hunter Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial Osteoarthritis and Cartilage Open Osteoarthritis Knee Implementation Randomized controlled trial Management programs |
title | Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial |
title_full | Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial |
title_fullStr | Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial |
title_full_unstemmed | Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial |
title_short | Protocol for the comparison of remote versus face-to-face osteoarthritis management programs (COASTAL): A randomized implementation trial |
title_sort | protocol for the comparison of remote versus face to face osteoarthritis management programs coastal a randomized implementation trial |
topic | Osteoarthritis Knee Implementation Randomized controlled trial Management programs |
url | http://www.sciencedirect.com/science/article/pii/S2665913125000834 |
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