Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000920695
Ethics application status
Approved
Date submitted
8/08/2023
Date registered
28/08/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
28/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of physical activity promotion by health professionals on physical activity levels of adults & young people receiving outpatient care (PROMOTE-PA study)
Scientific title
Promotion of Physical Activity by Health Professionals (PROMOTE-PA): A hybrid type I effectiveness-implementation cluster randomised controlled trial investigating the impact of physical activity promotion on physical activity levels of adults & young people receiving outpatient care.
Secondary ID [1] 309944 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROMOTE-PA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 330504 0
Condition category
Condition code
Public Health 327348 327348 0 0
Other public health
Physical Medicine / Rehabilitation 327349 327349 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a hybrid type I implementation effectiveness trial involves: a) Implementation strategies delivered by the research team to health professionals to support them to incorporate physical activity (PA) promotion into their routine care; and b) Evidence-based intervention (PA promotion) delivered by health professionals to their patients within their routine care.

IMPLEMENTATION STRATEGIES
The research team will work with all sites during a “Service Mapping” phase prior to site randomisation. All sites will take part in this Service Mapping process which will occur 4 weeks prior to the Implementation Period (intervention group) or 4 weeks prior to baseline (delayed support group). In this Service Mapping phase the research team will work with clinical team leaders at each site to identify factors relevant to the implementation process, including team members, clinical processes, patient journey, readiness for implementation, current PA promotion practices, and barriers and facilitators to PA promotion for health professionals and for patients.

Clinicians in sites randomised to the intervention group (early implementation support) will be offered implementation strategies to support and train them to incorporate PA counselling into their routine practice. Implementation strategies will be tailored to each site based on pre-implementation work conducted in PROMOTE-PA part 1 and the service mapping process. All sites in the intervention group will receive access to the educational online resource hub, and then sites will be offered additional implementation strategies (see additional options below). Those in the control group (delayed implementation support) will be offered the same strategies after completion of the control period.

The implementation strategies are based on literature describing barriers reported by health professionals that stop them from incorporating PA counselling into routine practice, as well as literature on existing programs and resources promoting PA in similar populations. The multi-faceted implementation strategies have also been informed by findings from pre-implementation work (PROMOTE-PA part 1 qualitative study conducted in 2022-23) which included consultation with local clinicians, community providers and patients to ensure the correct local influences are addressed.

All teams in the intervention phase will be given access to the online education & training resource hub (Implementation strategy 1). Implementation strategies 2-4 will be offered to all sites and tailored to the needs of each site.

Implementation strategy 1: Education and training – all teams
Mode of delivery/ where/ length: Online resource hub accessible through website. Maximum duration needed to review all content = 3 hours.
Time- frame: From the start of the implementation period onwards.
Intervention content: The online resources contain information, case studies and training videos supporting PA promotion as per the 5A’s approach outlined below, and implemented across diverse clinical areas relevant to the study sites (e.g. older adults, paediatrics, rheumatology, physiotherapy, etc). The training videos have been developed specifically for this study. Additional resources include: a comprehensive geographical map and list of community physical activity opportunities; Short educational videos presenting simulated clinical scenarios of health professionals delivering PA promotion targeting knowledge gaps identified in PROMOTE-PA part 1 pre-implementation study; Links to health professional and patient-facing resources on PA benefits, disease-specific considerations, examples of different physical activity options. Resources will include links to available resources e.g. Moving Medicine https://movingmedicine.ac.uk/; WHO: https://www.who.int/health-topics/physical-activity; and copies of study developed resources. Web portal analytics will be used to track usage of the different components of the online resource hub as a measure of adherence.

Implementation strategy 2: Tailored strategies to address community referral barriers
Mode of delivery/ where/ length: This will be tailored and determined with each team to address their specific context and the barriers they have with community referrals for their patients.
Time- frame: Start of implementation period
Intervention content: Research staff working with the PROMOTE-PA team will work with individual sites to provide training in finding PA opportunities, help to develop links with PA providers and/or develop referral resources. New models of service delivery will also be developed where indicated to support patients transitioning from hospital-based to community-based physical activity opportunities. Ongoing contact will be maintained with individual sites via weekly face-to-face visits during the implementation period, and via weekly phonecalls/emails during the remainder of the study period. A study audit of contact logs will be conducted to monitor adherence to the intervention.

Implementation strategy 3: Experts and clinical mentors
Mode of delivery/ where/ length: Mixed, online and in-person.
Time- frame: Start of implementation period
Intervention content: Could include presentations (e.g. how to do PA counselling) and Q&A sessions/discussions on incorporating PA promotion into clinical practice. These experts & clinical mentors have extensive experience in implementing PA promotion strategies in various clinical areas relevant to the study population (e.g. frail older adults, paediatrics, physiotherapy). These sessions will last approximately 60 minutes and take place once per fortnight during the study period. An audit of session attendance records will be conducted to monitor adherence.

Implementation strategy 4: Clinical champions
Mode of delivery/ where/ length: Mix of face-to-face & online delivery to clinical champion identified at each site
Time- frame: Start of implementation period
Intervention content: Identifying and supporting clinical champion at each site to drive implementation of PA promotion into routine practice. Support offered could include to identify/ modify/ develop resources for their team (including local Activity Directory or similar resource), identify & connect with appropriate PA opportunities, modify clinical assessment forms to include PA information to collect, audit and feedback with colleague between workshops. An audit of clinical champion correspondence & workshops will be conducted to monitor resources provided.

EVIDENCE-BASED INTERVENTION
The model for PA promotion within routine care in this trial is informed by the ‘5As’ promotion model:
1) Assess - All health professionals will be encouraged to assess their patients’ PA levels, provide brief advice about PA and implement one or more of the PA approaches as per the agreed implementation plan for that clinical team.
Follow up actions may include any or all of the following approaches (depending on each team’s client groups, clinical setting, and capacity):
2) Advise - make specific recommendations and advice on suitable PA options
3) Agree - collaboratively set goals and develop a PA action plan
4) Assist - collaboratively identify barriers and potential solutions
5) Arrange - arrange referral to a PA program with follow-up

Clinicians in the early implementation support group can also refer their patients who are interested, to the Physical Activity Linkage Program. Patients who participate in the Physical Activity Linkage Program will receive:
I. Assessment - An initial session of up to 1 hour from an experienced physiotherapist or exercise physiologist to identify what support they may need/want to be more active. This session may be provided face to face, on the phone or online.
II. Tailored advice about suitable PA opportunities in the community.
III. Development of an individualised plan to help the patient increase their PA that includes referral to suitable PA opportunities/services.
IV. An optional second session with an experienced physiotherapist or exercise physiologist to discuss the plan and provide additional support to help the patient get started and keep on being active.
An audit of session attendance checklists will be conducted to monitor adherence to the intervention.

PA promotion seeks to change health behaviour as a means of primary or secondary prevention of life-style related chronic health conditions. This may include physical activity counselling intervention which is underpinned by theoretical models of behaviour change (COM-B, Self Determination Theory, Social Cognitive Theory), Motivational Interviewing and incorporates behaviour change techniques shown to increase PA in the general population as well as people with physical disabilities.
Intervention code [1] 326423 0
Prevention
Intervention code [2] 326424 0
Behaviour
Intervention code [3] 326425 0
Lifestyle
Comparator / control treatment
Teams randomised to the control group (delayed implementation support) will receive no supported implementation during the intervention period. These teams will continue to deliver usual care to their patients. Sites in this group will be able to recruit patients immediately after randomisation. Once sites have reached their recruitment target for patient recruitment (between 10-30 patients recruited), or once three months has passed, they will be offered the supported implementation strategies as per the intervention outlined above. Implementation measures will be collected for these sites following their implementation period. Patient-level data will only be collected at sites that routinely collect patient PA data, i.e., no additional patient-level data collection will occur at these sites during the period in which the clinical staff receive the supported implementation strategies.
Control group
Active

Outcomes
Primary outcome [1] 335220 0
Self-reported moderate to vigorous physical activity (minutes per week) - patient-level outcome
Timepoint [1] 335220 0
Intervention group: Baseline, 3 months (primary endpoint) and 6 months post-implementation commencement
Control group: Baseline, 3 months (primary endpoint) and 6 months post randomisation
Secondary outcome [1] 423532 0
Patient self-reported frequency of balance/functional training (days per week)
Timepoint [1] 423532 0
Intervention group: Baseline, 3 months and 6 months post-implementation commencement
Control group: Baseline, 3 months and 6 months post randomisation
Secondary outcome [2] 423533 0
Self-reported quality of life - utility score from the EQ-5D-5L - adults; EQ-5D-Youth - children
Timepoint [2] 423533 0
Intervention group: Baseline, 3 months and 6 months post-implementation commencement
Control group: Baseline, 3 months and 6 months post randomisation
Secondary outcome [3] 423534 0
Patient self-reported mobility (PROMIS 29+2 Profile v 2.1) - adults
Timepoint [3] 423534 0
Intervention group: Baseline, 3 months and 6 months post-implementation commencement
Control group: Baseline, 3 months and 6 months post randomisation
Secondary outcome [4] 423535 0
Global perceived change in mobility (10-point scale from -5 'a lot worse' to +5 'a lot better')
Timepoint [4] 423535 0
Intervention group: Baseline, 3 months and 6 months post-implementation commencement
Control group: Baseline, 3 months and 6 months post randomisation
Secondary outcome [5] 423536 0
Self-reported number of days being active more than 60 minutes - children
Timepoint [5] 423536 0
Intervention group: Baseline, 3 months and 6 months post-implementation commencement
Control group: Baseline, 3 months and 6 months post randomisation
Secondary outcome [6] 423537 0
Patient self-reported most common types of physical activity
Timepoint [6] 423537 0
Intervention group: Baseline, 3 months and 6 months post-implementation commencement
Control group: Baseline, 3 months and 6 months post randomisation
Secondary outcome [7] 423538 0
Global perceived change in physical activity (10-point scale from -5 'a lot less' to +5 'a lot more')
Timepoint [7] 423538 0
Intervention group: Baseline, 3 months and 6 months post-implementation commencement
Control group: Baseline, 3 months and 6 months post randomisation
Secondary outcome [8] 423539 0
Delivery of implementation strategies: Adoption - the number of clinical teams who participated in the study compared to the number who were identified by the research team and invited to participate (presented as a percentage), assessed by an audit of study records maintained by research team.
Timepoint [8] 423539 0
Recruitment period of 30 clinical teams.
Secondary outcome [9] 423540 0
Delivery of implementation strategies: Dose delivered - Average dose (hours) per clinical team of implementation strategies delivered, measured using a study-specific training and resources log (intervention group, within group measure).
Timepoint [9] 423540 0
Intervention group only: Baseline, 6 months post-implementation commencement
Secondary outcome [10] 423541 0
Delivery of implementation strategies: Reach - Proportion of the different types of clinical teams that participate in the implementation strategies measured from the study recruitment log (no between group comparison).
Timepoint [10] 423541 0
At completion of recruitment of 30 clinical teams.
Secondary outcome [11] 423542 0
Delivery of implementation strategies: Fidelity - Proportion of health professionals who deliver PA promotion, measured by self-reported clinician checklist of PA promotion strategies using the “5As” approach, as per each team’s implementation plan developed during the implementation period. (Intervention group only, within-group measure)
Timepoint [11] 423542 0
Intervention group only: Baseline, 6 months post-implementation commencement
Secondary outcome [12] 423666 0
Implementation determinant: Adaptability of the implementation strategies: Research study team to evaluate number of different ways support to deliver PA promotion was offered to clinical teams, assessed by site-specific study records. (Intervention group only, within group measure)
Timepoint [12] 423666 0
Intervention group only: 6 months post-implementation commencement
Secondary outcome [13] 423667 0
Implementation determinant: Feasibility of the implementation strategies - Feasibility of PA promotion support strategies assessed by semi-structured face-to-face interviews with health professionals.
(Intervention group only, within-group measure)
Timepoint [13] 423667 0
Intervention group only: 6 months post-implementation commencement
Secondary outcome [14] 423670 0
Implementation determinant: Cost of the implementation strategies - Trial based site-specific records for delivery of the implementation strategies. (Intervention group only, within-group measure)
Timepoint [14] 423670 0
Intervention group only: Duration of the 6-month study period.
Secondary outcome [15] 423671 0
Implementation determinant; Cost of the PA promotion intervention - Trial based site-specific records for delivery of the PA promotion interventions. (Intervention group only, within-group measure)
Timepoint [15] 423671 0
Intervention group only: Duration of the 6-month study period.
Secondary outcome [16] 423672 0
Implementation determinant: Satisfaction with the implementation strategies - Study- specific survey of health professionals assessing their self-reported satisfaction with the implementation support strategies.
(Intervention group only, within-group measure)
Timepoint [16] 423672 0
Intervention group only: 6 months post-implementation commencement
Secondary outcome [17] 423673 0
Implementation determinant: Complexity of the implementation strategies - Semi-structured face-to-face Qualitative interviews with health professionals assessing their perception of complexity of the implementation strategies.
(Intervention group only, within-group measure)
Timepoint [17] 423673 0
Intervention group only: 6 months post-implementation commencement
Secondary outcome [18] 423674 0
Implementation determinant: Self-efficacy of the implementation strategies - Semi-structured face-to-face interviews with clinical team leaders assessing belief in ability to achieve implementation goals.
(Intervention group only, within-group measure)
Timepoint [18] 423674 0
Intervention group only: 6 months post-implementation commencement
Secondary outcome [19] 424237 0
Implementation determinant: Acceptability of the implementation strategies - Acceptability of PA promotion support strategies assessed by study-specific survey of health professionals. (Intervention group only, within-group measure)
Timepoint [19] 424237 0
Intervention group only: 6 months post-implementation commencement
Secondary outcome [20] 425583 0
Self-reported quality of life - Visual Analog Scale (VAS) from the EQ-5D-5L - adults; EQ-5D-Youth - children
Timepoint [20] 425583 0
Intervention group: Baseline, 3 months and 6 months post-implementation commencement
Control group: Baseline, 3 months and 6 months post randomisation
Secondary outcome [21] 425585 0
Implementation measure: Delivery of PA promotion intervention: Reach - 1. Medical record audit assessing delivery of PA promotion to patients. (Intervention group only, within group measure)
Timepoint [21] 425585 0
Intervention group only: Baseline & 6-months post implementation commencement
Secondary outcome [22] 425597 0
Implementation measure: Delivery of PA promotion intervention: Reach - 2. Proportion of patients who received PA promotion, measured by patient self-reported study specific survey assessing their impressions of healthcare over the previous 6 months. (Intervention group only, within group measure)
Timepoint [22] 425597 0
Intervention group only: Baseline, 6 months post-implementation commencement
Secondary outcome [23] 425598 0
Implementation measure: Delivery of PA promotion intervention: Fidelity - Proportion of implementation strategies used by each clinical team compared with the strategies identified in the Service Mapping implementation plan. Documented by research study team on a checklist tailored for each clinical site. (Intervention group only, within group measure)
Timepoint [23] 425598 0
6-months post-implementation commencement
Secondary outcome [24] 425601 0
Implementation determinant: Acceptability of PA promotion intervention - Assessed by qualitative semi-structured face-to-face interviews with patients and health professionals. (Intervention group only, within-group measure)
Timepoint [24] 425601 0
6-months post-implementation support commencement
Secondary outcome [25] 425602 0
Implementation determinant: Adaptability of PA promotion intervention - Number of different PA promotion interventions were offered to clinical teams , assessed by site-specific study records. (Intervention group only, within group measure)
Timepoint [25] 425602 0
6-months post-implementation commencement.
Secondary outcome [26] 425603 0
Implementation determinant: Feasibility of the PA promotion intervention - Qualitative semi-structured face-to-face interviews with health professionals. (Intervention group only, within-group measure)
Timepoint [26] 425603 0
Intervention group only: 6-months post-implementation commencement
Secondary outcome [27] 425604 0
Implementation determinant: Compatibility of implementation strategies - Semi-structured face-to-face interviews of health professionals assessing how the delivery of implementation support fitted in with clinical workloads. (Intervention group only, within-group measure)
Timepoint [27] 425604 0
6-months post-implementation commencement.
Secondary outcome [28] 425605 0
Implementation determinant: Compatibility of PA promotion intervention- Semi-structured face-to-face interviews of health professionals assessing how the delivery of PA promotion interventions fitted in with clinical workloads. (Intervention group only, within-group measure)
Timepoint [28] 425605 0
6-months post-implementation commencement.
Secondary outcome [29] 425606 0
Implementation determinant: Satisfaction with the PA promotion intervention - Semi-structured face-to-face interviews of health professionals assessing satisfaction with PA promotion interventions.
(Intervention group only, within-group measure)
Timepoint [29] 425606 0
6-months post-implementation commencement.
Secondary outcome [30] 425608 0
Implementation determinant: Complexity of the PA promotion interventions - Semi-structured face-to-face Qualitative interviews with health professionals assessing their perception of complexity of the PA promotion interventions. (Intervention group only, within-group measure)
Timepoint [30] 425608 0
6-months post-implementation commencement
Secondary outcome [31] 425609 0
Implementation determinant: Self-efficacy of PA promotion intervention - Study-specific survey of health professionals assessing self-confidence in ability to deliver PA promotion. (Intervention group only, within-group measure)
Timepoint [31] 425609 0
Intervention group only: 6 months post-implementation commencement
Secondary outcome [32] 426011 0
Implementation determinant (delivery of implementation strategies): Culture - assessed by semi-structured interviews with health professionals and managers (intervention group only, within group measure)
Timepoint [32] 426011 0
6-months post-implementation commencement
Secondary outcome [33] 426012 0
Implementation determinant (delivery of PA promotion intervention): Culture - clinicians' perceptions on the importance of delivering PA promotion, assessed by study-specific survey
Timepoint [33] 426012 0
6-months post-implementation commencement
Secondary outcome [34] 426013 0
Implementation determinant (delivery of PA promotion intervention): Culture - clinicians' perceptions on the importance of delivering PA promotion, assessed by semi-structured face-to-face interviews with health professionals
Timepoint [34] 426013 0
6-months post-implementation commencement

Eligibility
Key inclusion criteria
Health professional participants
- A health professional providing outpatient or community- based clinical services within a participating clinical service in SWSLHD, SLHD, SCHN, SESLHD, WSLHD or within NSW private outpatient physiotherapy practice or specialist medical service.
- Health professionals who have the scope to include physical activity promotion in their practice, including physiotherapists, occupational therapists, geriatricians, rehabilitation physicians, rheumatologists, endocrinologists, surgeons, sports physicians, exercise physiologists and nurses.
- Willingness to provide informed consent and willingness to participate and comply with the study requirements.

Patient participants
- Adults or school-aged children living in the community who are attending a participating clinical service and who are willing to receive additional support to be more physically active.
- No contra-indications to increase PA.
- Sufficient language capabilities to respond to written or verbal questionnaires in English, Arabic or Vietnamese.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Health professional participants
• Health professionals who are not working in relevant clinical areas outlined above.
Patient participants
• Participants who have a medical condition precluding physical activity/exercise
• Insufficient language capabilities to respond to written or verbal questionnaires in English, Arabic or Vietnamese
• Progressive neurological disease that severely affects function
• Other e.g., delirium, severe psychiatric disorders

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinical teams that agree to participate will be recruited as clusters and allocated to receive the supported implementation strategy immediately or after a delay. To ensure concealed allocation, allocation will be managed outside of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clinical teams that agree to participate will be recruited as clusters and randomised to receive the supported implementation strategy immediately or after a delay. The randomisation schedule will be generated in STATA statistical software and uploaded into Research Data Electronic Capture (REDCap) data management software. The randomisation schedule includes stratified block randomisation, stratifying for two dichotomous variables: i) anticipated number of occasions of service (services likely to provide 1-2 occasions of service during study period vs services likely to provide 3 or more occasions of service during study period), and ii) patient population (adults vs paediatrics) [24]. When there is a team(s) to randomise, the study coordinator will enter the team into REDCap to generate group allocation. To ensure concealed allocation, research staff who are responsible for generating the schedule and uploading it into REDCap are not involved in recruiting or randomising teams.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other design features
This is a cluster randomised trial using a type I effectiveness-implementation hybrid design in that it enables the testing of a clinical intervention while gathering observational data on the implementation strategies. Prior to randomisation, all teams will take part in a Service Mapping Process to collect data relating to the implementation determinants (context, culture, characteristics of the health professionals within the clinical team). Thirty clinical teams will be randomly allocated to the Early Implementation Support group to receive the intervention immediately or the Delayed Implementation Support group (to receive the implementation strategy after they have recruited their anticipated quota of patients). Each clinical team will recruit 10-50 patients (estimated average 24, n=720) to collect effectiveness outcomes at baseline, 3-months and 6-months. Patients being treated by health professionals in the Early Implementation Support group will receive physical activity counselling plus other support (tailored to each site as per clinical population and health professional type) during their outpatient consultation. Patients being treated by health professionals in the Delayed Implementation Support group will receive their routine care. Patient participants will not be blinded as the physical activity outcomes are self-reported. Health professional participants will not be blinded as they will be aware of whether they are receiving the supported implementation strategies. Data analysts conducting the primary analysis will be blinded to group allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation

Recruitment of 720 patients across 30 clusters (average 24 participants per cluster) will be sufficient to detect an absolute difference of 75 minutes in moderate-vigorous physical activity (180 minutes in the Early Implementation Support group and 105 minutes in the Delayed Implementation Support group, SD = 204 minutes). This calculation used 80% power, alpha = 0.05, ICC = 0.05 and allowed for a 20% drop out rate. Calculations were undertaken using clustersampsi in Stata 16.

Quantitative analysis

We will use statistical models to assess between-group differences in quantitative outcomes at follow up. Linear regression adjusting for baseline values of outcomes where possible will be used for continuous outcomes and logistic regression will be used for dichotomous outcomes.

Qualitative analysis

We will use thematic data analysis to analyse the data from interviews and focus groups.
Transcripts will be imported into the qualitative software program NVivo 10 (version 10, QSR International, Melbourne, VIC, Australia). For interviews and focus groups, thematic analysis of the audio files, written transcripts and detailed field-notes will be an iterative process that will occur during and after the period of data collection. We will develop a framework to code all data based on the study aims, interview questions and the major topic areas. Significant ideas and themes will be coded and reviewed by members of the research team. This process will be continued until a point when no new findings are identified from the texts and agreement is reached about the final list of themes by research team members.

Economic analysis

The economic analysis will be conducted alongside the trial and will aim to establish the cost-effectiveness and cost-utility of the intervention compared to no intervention from a health funder perspective. The time horizon will be 2 years (including the 6-month trial duration).
The trial-based economic evaluation will take the perspective of the hospital-based healthcare funder. Health care costs (hospital-based inpatient & outpatient services, emergency department utilisation), and intervention and implementation costs will be collected over the trial period for both groups.

Using mean costs and mean health outcomes in each trial arm, the incremental costs per 1) additional person achieving a meaningful improvement in PA; 2) additional person with any improvement in quality of life (from PROMIS-29); and 3) quality-adjusted life years (QALY) gained of the intervention group compared with control group at 6 months and 2 years will be calculated.
Results will be plotted on a cost-effectiveness plane. Bootstrapping will be used to estimate a distribution around costs and health outcomes, and to calculate the confidence intervals around the incremental cost-effectiveness ratios. One-way and multi-way sensitivity analyses will be conducted around key variables and a probabilistic sensitivity analysis will estimate joint uncertainty in all parameters. A cost-effectiveness acceptability curve will be plotted to provide information about the probability that the intervention is cost-effective given a range of willingness to pay threshold for improvements in each of the three outcomes (PA, quality of life and QALY).
Modelled analyses will explore the longer- term intervention cost-effectiveness using Markov and/or microsimulation models with uptake and outcome data from the trial. This will enable us to apply the learnings from this work to the broader context and will guide future program scale-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/10/2023
Actual
8/02/2024
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
720
Accrual to date
46
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25046 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 25047 0
Balmain Hospital - Balmain
Recruitment hospital [3] 25048 0
Canterbury Hospital - Campsie
Recruitment hospital [4] 25049 0
Concord Repatriation Hospital - Concord
Recruitment hospital [5] 25050 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [6] 25051 0
Blacktown Hospital - Blacktown
Recruitment hospital [7] 25052 0
Westmead Hospital - Westmead
Recruitment hospital [8] 25053 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [9] 25055 0
Sydney Children's Hospital - Randwick
Recruitment hospital [10] 25056 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [11] 25057 0
Liverpool Hospital - Liverpool
Recruitment hospital [12] 25058 0
Fairfield Hospital - Prairiewood
Recruitment hospital [13] 25059 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [14] 25060 0
Bowral Hospital - Bowral
Recruitment hospital [15] 25061 0
Prince of Wales Hospital - Randwick
Recruitment hospital [16] 25062 0
St George Hospital - Kogarah
Recruitment hospital [17] 25063 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 40708 0
2050 - Camperdown
Recruitment postcode(s) [2] 40709 0
2041 - Balmain
Recruitment postcode(s) [3] 40710 0
2194 - Campsie
Recruitment postcode(s) [4] 40711 0
2139 - Concord
Recruitment postcode(s) [5] 40712 0
2144 - Auburn
Recruitment postcode(s) [6] 40713 0
2148 - Blacktown
Recruitment postcode(s) [7] 40714 0
2145 - Westmead
Recruitment postcode(s) [8] 40716 0
2031 - Randwick
Recruitment postcode(s) [9] 40717 0
2200 - Bankstown
Recruitment postcode(s) [10] 40718 0
2170 - Liverpool
Recruitment postcode(s) [11] 40719 0
2176 - Prairiewood
Recruitment postcode(s) [12] 40720 0
2560 - Campbelltown
Recruitment postcode(s) [13] 40721 0
2576 - Bowral
Recruitment postcode(s) [14] 40722 0
2217 - Kogarah
Recruitment postcode(s) [15] 40723 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 314123 0
Government body
Name [1] 314123 0
National Health & Medical Research Council
Country [1] 314123 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, 2006 NSW Australia
Country
Australia
Secondary sponsor category [1] 316037 0
None
Name [1] 316037 0
Address [1] 316037 0
Country [1] 316037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313259 0
Sydney Local Health District Human Research Ethics Committee - Royal Prince Alfred Hospital
Ethics committee address [1] 313259 0
Ethics committee country [1] 313259 0
Australia
Date submitted for ethics approval [1] 313259 0
23/05/2023
Approval date [1] 313259 0
03/07/2023
Ethics approval number [1] 313259 0
X23-0197

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

Contacts
Principal investigator
Name 127510 0
Prof Cathie Sherrington
Address 127510 0
Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, PO Box M179, Missenden Road, NSW 2050, Australia
Country 127510 0
Australia
Phone 127510 0
+61 286276265
Fax 127510 0
Email 127510 0
cathie.sherrington@sydney.edu.au
Contact person for public queries
Name 127511 0
Cathie Sherrington
Address 127511 0
Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, PO Box M179, Missenden Road, NSW 2050, Australia
Country 127511 0
Australia
Phone 127511 0
+61 286276265
Fax 127511 0
Email 127511 0
cathie.sherrington@sydney.edu.au
Contact person for scientific queries
Name 127512 0
Cathie Sherrington
Address 127512 0
Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, PO Box M179, Missenden Road, NSW 2050, Australia
Country 127512 0
Australia
Phone 127512 0
+61 286276265
Fax 127512 0
Email 127512 0
cathie.sherrington@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?
De-identified patient-level data for primary and secondary outcomes.
When will data be available (start and end dates)?
Data will be available when the main study results paper is published. There is no end date for data availability.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
The data will be made available on the University of Sydney’s open access institutional repository, Sydney eScholarship repository (https://ses.library.usyd.edu.au/). In the interim, inquiries can be directed to the Chief Investigator Professor Cathie Sherrington, cathie.sherrington@sydney.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



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.