Trial Review

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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] 312256 0
None
Universal Trial Number (UTN)
Trial acronym
COASTAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 333963 0
Knee pain 333964 0
Condition category
Condition code
Musculoskeletal 330633 330633 0 0
Osteoarthritis
Public Health 330634 330634 0 0
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] 328705 0
Treatment: Other
Intervention code [2] 328818 0
Lifestyle
Intervention code [3] 328819 0
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] 338379 0
Between group change in average knee pain during walking
Timepoint [1] 338379 0
At Baseline and 6 months post-Baseline
Secondary outcome [1] 435685 0
Between group changes in knee pain on walking
Timepoint [1] 435685 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [2] 435686 0
Between group changes in knee specific pain
Timepoint [2] 435686 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [3] 435687 0
Between group changes at 6- and 12-months in weight/BMI
Timepoint [3] 435687 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [4] 435688 0
Between group changes in ability to participate in life
Timepoint [4] 435688 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [5] 435689 0
Between group changes in physical activity
Timepoint [5] 435689 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [6] 435690 0
Between group changes in health related quality of life
Timepoint [6] 435690 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [7] 435691 0
Between group changes in global rating of knee change
Timepoint [7] 435691 0
At 6 and 12 months post-Baseline only
Secondary outcome [8] 435692 0
Between group changes in depressive symptoms
Timepoint [8] 435692 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [9] 435693 0
Between group changes in sleep quality
Timepoint [9] 435693 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [10] 435695 0
Between group changes in willingness for joint replacement surgery
Timepoint [10] 435695 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [11] 438352 0
Between group changes in knee function
Timepoint [11] 438352 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [12] 438353 0
Between group changes in symptoms
Timepoint [12] 438353 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [13] 438354 0
Between group changes in quality of life (QoL)
Timepoint [13] 438354 0
At Baseline and at 6 and 12 months post-Baseline
Secondary outcome [14] 438356 0
Between group changes in satisfaction with knee symptoms
Timepoint [14] 438356 0
At 6 and 12 months post-Baseline only
Secondary outcome [15] 438357 0
Between group changes in satisfaction with treatment
Timepoint [15] 438357 0
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?
No
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] 316634 0
Government body
Name [1] 316634 0
NHMRC
Country [1] 316634 0
Australia
Funding source category [2] 316635 0
Charities/Societies/Foundations
Name [2] 316635 0
Ramsay Health Research Foundation
Country [2] 316635 0
Australia
Funding source category [3] 316636 0
Other Collaborative groups
Name [3] 316636 0
Institute of Bone and Joint Research
Country [3] 316636 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318820 0
None
Name [1] 318820 0
Address [1] 318820 0
Country [1] 318820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315416 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315416 0
Ethics committee country [1] 315416 0
Australia
Date submitted for ethics approval [1] 315416 0
26/07/2024
Approval date [1] 315416 0
03/09/2024
Ethics approval number [1] 315416 0
2024/ETH01461

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134642 0
Prof David Hunter
Address 134642 0
Kolling Institute, Royal North Shore Hospital, 10 Westbourne St, St Leonards NSW 2065
Country 134642 0
Australia
Phone 134642 0
+61 2 9463 1887
Fax 134642 0
Email 134642 0
[email protected]
Contact person for public queries
Name 134643 0
Scott Chery
Address 134643 0
Kolling Institute, Royal North Shore Hospital, 10 Westbourne St, St Leonards NSW 2065
Country 134643 0
Australia
Phone 134643 0
+61 2 9463 1898
Fax 134643 0
Email 134643 0
[email protected]
Contact person for scientific queries
Name 134644 0
Jocelyn Bowden
Address 134644 0
Kolling Institute, Royal North Shore Hospital, 10 Westbourne St, St Leonards NSW 2065
Country 134644 0
Australia
Phone 134644 0
+61 2 9463 1898
Fax 134644 0
Email 134644 0
[email protected]

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 ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24042Study protocol  [email protected]
24043Informed consent form  [email protected]
24044Statistical analysis plan  [email protected]
24045Ethical approval  [email protected]



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.