ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12624000996561

Ethics application status

Approved

Date submitted

26/07/2024

Date registered

14/08/2024

Date last updated

14/10/2024

Date data sharing statement initially provided

14/08/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

COASTAL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Knee osteoarthritis

Knee pain

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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).

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The control group are participants with knee osteoarthritis referred to OACCP who do not wish to be randomised to any of the three treatment arms, but are happy to still participate in the study. They will continue with their usual care and complete self-report questionnaires at baseline, 6 months and 12 months. For the purposes of this study, “usual care” is defined as however the participant has been controlling and managing their knee OA pain in their day-to-day life, whether that may include no additional care, or care from their GP or other health practitioners.

Control group

Active

Outcomes

Primary outcome [1]

Between group change in average knee pain during walking

Timepoint [1]

At Baseline and 6 months post-Baseline

Secondary outcome [1]

Between group changes in knee pain on walking

Timepoint [1]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [2]

Between group changes in knee specific pain

Timepoint [2]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [3]

Between group changes at 6- and 12-months in weight/BMI

Timepoint [3]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [4]

Between group changes in ability to participate in life

Timepoint [4]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [5]

Between group changes in physical activity

Timepoint [5]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [6]

Between group changes in health related quality of life

Timepoint [6]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [7]

Between group changes in global rating of knee change

Timepoint [7]

At 6 and 12 months post-Baseline only

Secondary outcome [8]

Between group changes in depressive symptoms

Timepoint [8]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [9]

Between group changes in sleep quality

Timepoint [9]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [10]

Between group changes in willingness for joint replacement surgery

Timepoint [10]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [11]

Between group changes in knee function

Timepoint [11]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [12]

Between group changes in symptoms

Timepoint [12]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [13]

Between group changes in quality of life (QoL)

Timepoint [13]

At Baseline and at 6 and 12 months post-Baseline

Secondary outcome [14]

Between group changes in satisfaction with knee symptoms

Timepoint [14]

At 6 and 12 months post-Baseline only

Secondary outcome [15]

Between group changes in satisfaction with treatment

Timepoint [15]

At 6 and 12 months post-Baseline only

Eligibility

Key inclusion criteria

• Referred to participating OACCP clinic by primary care (e.g. GP, physiotherapist, allied health professional) or other non-surgical wait list pathway
• triaged by the OACCP as category 2 or 3 (as applicable to OACCP site)
• 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

Minimum age

45 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• 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
• 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).

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer - REDCap randomisation module

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Prior to study activation, the study statistician will prepare a computer-generated randomisation schedule considering the sample size, and allocation rate of 1:1:1, and random permuted block sizes.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data analysis will be blinded, based on the intention to treat principles, and guided by a detailed statistical analysis plan. The mean difference in pain on walking between the groups at six months (primary outcome) will be compared using the ANCOVA model and adjusting for baseline pain scores. Baseline descriptive statistics of the participant will be presented to allow comparison of treatment groups.

For continuous outcome measures, differences in mean change (baseline minus follow-up) will be compared between groups using generalised estimating equations to account for within-practice correlation with exchangeable correlation, robust standard errors, and adjusting for the baseline value of the outcome variable. For binary outcomes, GEEs will be fitted using a logit link function assuming an exchangeable correlation structure and robust variance estimation, adjusting for stratification variables, with results presented as odds ratios. To aid interpretation, risk differences will also be calculated using marginal probabilities.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

31/10/2024

Actual

Date of last participant enrolment

Anticipated

30/11/2026

Actual

Date of last data collection

Anticipated

30/11/2027

Actual

Sample size

Target

1348

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Ramsay Health Research Foundation

Address [2]

Country [2]

Australia

Funding source category [3]

Other Collaborative groups

Name [3]

Institute of Bone and Joint Research

Address [3]

Country [3]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/07/2024

Approval date [1]

03/09/2024

Ethics approval number [1]

2024/ETH01461

Summary

Brief 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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof David Hunter

Address

Kolling Institute, Royal North Shore Hospital, 10 Westbourne St, St Leonards NSW 2065

Country

Australia

Phone

+61 2 9463 1887

Fax

david.hunter@sydney.edu.au

Contact person for public queries

Name

Scott Chery

Address

Kolling Institute, Royal North Shore Hospital, 10 Westbourne St, St Leonards NSW 2065

Country

Australia

Phone

+61 2 9463 1898

Fax

coastal.study@sydney.edu.au

Contact person for scientific queries

Name

Jocelyn Bowden

Address

Kolling Institute, Royal North Shore Hospital, 10 Westbourne St, St Leonards NSW 2065

Country

Australia

Phone

+61 2 9463 1898

Fax

coastal.study@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Initially, individual participant data underlying published results will be available (after de-identification). Prior to the other data may be available at the discretion of the CIs.

When will data be available (start and end dates)?

Immediately following publication or as agreed by the CIs, no end date has been determined.

Available to whom?

Initially, data will be available to researchers who provide a methodologically sound proposal. Data will become available through a public database once the major findings have been published.

Available for what types of analyses?

No restrictions

How or where can data be obtained?

Initially, access will be subject to approvals by the Principal Investigator, and may require a data access agreement. Data will eventually be submitted to a public database.
Principal Investigator: Prof David Hunter (david.hunter@sydney.edu.au)

What supporting documents are/will be available?

Doc. No.	Type	Email
24042	Study protocol	coastal.study@sydney.edu.au
24043	Informed consent form	coastal.study@sydney.edu.au
24044	Statistical analysis plan	coastal.study@sydney.edu.au
24045	Ethical approval	coastal.study@sydney.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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