RecruitingACTRN12624000996561

Comparison of Osteoarthritis Management Programs: remote versus face-to-face care (COASTAL)

Comparison of Osteoarthritis Management Programs: remote versus face-to-face care on knee pain and functional outcomes (COASTAL)


Sponsor

The University of Sydney

Enrollment

1,348 participants

Start Date

Mar 26, 2025

Study Type

Interventional

Conditions

Summary

OA is a condition that affects the joints and causes pain and stiffness. In Australia, around three million people have OA, but the way we currently treat OA isn't always based on the best evidence. Sometimes, the care is not well coordinated, not very helpful, or not suitable for the person's needs. The COASTAL study is a research study testing three different ways of providing this care: in-person (face-to-face), or through technology like telehealth (video or phone calls) or using an online app. This research study will compare how well these different programs work at improving pain for people with knee OA. We hope the results of this study will help policymakers and healthcare providers decide on the best way to organise services for people with knee OA. We hypothesise that the three methods of delivering knee OA management programs will be non-inferior to each other for reducing average knee pain on walking.


Eligibility

Sex: Both males and femalesMin Age: 45 Yearss

Inclusion Criteria6

  • Referred to participating OACCP clinic by a health professional
  • aged 45 years and above
  • activity related knee pain related to OA for at least 3 months
  • knee pain on walking between 4 and 8 inclusive on an 11-point numerical rating scale (NRS) the week prior to screening and confirmed prior to enrolment,
  • prepared to complete the suite of online surveys at 3 timepoints over 1 year
  • has a smart phone or device, and internet access

Exclusion Criteria7

  • non-English speaker who requires a translator
  • unable to give informed consent (including people in high level care, or with any medical condition which precludes giving informed consent, e.g. dementia, intellectual disability, mental health issues)
  • non-ambulatory or very limited mobility
  • scheduled for knee surgery (including waitlist)
  • triaged by the OACCP as category 1/urgent
  • terminally ill, has rheumatoid arthritis, gout or any other severe inflammatory condition, or is undergoing active treatment for serious medical conditions which would preclude participation in this study (e.g. cancer treatment).
  • health condition/s which, in the opinion of the study doctor, would preclude them from taking part in an OA management program

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Interventions

We will compare three services delivery approaches to osteoarthritis (OA) care. The three interventional approaches are the Osteoarthritis Chronic Care Program (OACCP) face-to-face hospital clinical a

We will compare three services delivery approaches to osteoarthritis (OA) care. The three interventional approaches are the Osteoarthritis Chronic Care Program (OACCP) face-to-face hospital clinical approach, a telehealth approach, and an app (OA Coach). Participants randomised to the treatment arms will receive the interventions over 6-months. Appropriate to the mode of delivery, the interventions will deliver a standardised participant needs assessment; OA education; develop a collaborative management plan for each individual that selects appropriate self-management behaviours for therapeutic exercise, physical activity, pain management, and/or weight management. A report to each participant's referring health professional using a standardised template will be prepared after randomisation, and at trial conclusion. Each intervention arm will receive: • OACCP arm: participants will receive the OACCP model of care, as currently delivered through hospitals in NSW Australia. The delivery of the model will vary depending on the host hospital’s capacity/services, but will typically comprise of participant visits with a multidisciplinary team (e.g. physiotherapists, occupational therapists, dietitians), with care overseen by an OACCP Musculoskeletal Coordinator (usually a physiotherapist). There will be 3 sessions (~1-2 hrs each) over the 6 months approximately every 2 months during months 1, 3/4 and 6. Adherence will be monitored by participant self-reported monthly surveys and session attendance checklists. • Telehealth arm: participants will receive a remotely delivered telehealth service delivered by Ramsay Connect. This model is based upon the Optimising primary care management of knee osteoarthritis (PARTNER) PARTNER model of service delivery, tested previously. The Care Support Team (CST) will be an allied health team with members from a range of professions (e.g. Physiotherapists, Dietitians), trained in behaviour change techniques and OA management and will provide participants tailored OA educational materials, exercise programs, or weight-loss programs, as appropriate. There will be ~6-10 sessions (approx. one hour for the first session, and then subsequent sessions approx. 10-15 minutes each) delivered to participants by phone call over 6-months, ideally at least one phone session per month. Adherence will be monitored by participant self-reported monthly surveys and session attendance checklists. • OA Coach arm: participants will be guided in their care through a smartphone app. Interaction with the app will be at the participants' discretion, but they will be encouraged to login at least daily. Participants will complete assessments involving the input of anthropometric measurements and completion of pain scales, be able to set their own goals, be provided a display of their progress including steps (participants will be provided a Fitbit activity tracker to wear during the trial alongside the app), weight loss and pain levels. The learning page will cover core components of OA management, including physical activity, exercise, weight management, sleep hygiene, mood, and flare management. The duration off each app interaction is expected to take approx. 10-15 minutes each. Adherence will be monitored by participant self-reported monthly surveys and back-end monitoring progress (e.g. steps being uploaded).


Locations(8)

Royal North Shore Hospital - St Leonards

NSW, Australia

Hornsby Ku-ring-gai Hospital - Hornsby

NSW, Australia

The Sutherland Hospital - Caringbah

NSW, Australia

Bega District Hospital - Bega

NSW, Australia

Westmead Hospital - Westmead

NSW, Australia

Port Macquarie Base Hospital - Port Macquarie

NSW, Australia

Coffs Harbour Base Hospital - Coffs Harbour

NSW, Australia

Wollongong Hospital - Wollongong

NSW, Australia

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ACTRN12624000996561


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