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Trial registered on ANZCTR

Registration number

ACTRN12623000584639

Ethics application status

Approved

Date submitted

11/05/2023

Date registered

29/05/2023

Date last updated

23/06/2024

Date data sharing statement initially provided

29/05/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Staying Active with Multimorbidity In Acute hospital (StAMInA) Trial: a randomised controlled trial investigating the feasibility of allied health assistant delivered mobility rehabilitation for patients with multimorbidity in an acute hospital setting

Scientific title

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

StAMInA Trial

Linked study record

Health condition

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

Multimorbidity

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Name of intervention: Allied health assistant provision of routine acute mobility rehabilitation
Who will deliver the intervention and what is their training: The intervention will be delivered by a senior allied health assistant (grade 3). The allied health assistant will have a certificate IV allied health assistant qualification. A mid-level (grade 2) physiotherapist will supervise the senior allied health assistant as per health network clinical supervision guidelines. This supervision will include monthly meetings to discuss professional and clinical skill development in the management of people with multimorbidity. It will also involve direct supervision/observation of the senior allied health assistant’s management of patients with multimorbidity. Note that this is the only difference between the exposure and comparator groups; all other procedures/protocols are the same.
Mode of delivery: Individual, face-to-face
Dose: Daily therapy provided on weekdays (i.e. daily therapy 5x per week) until discharge from acute hospital. Initial physiotherapy assessment may occur on a Saturday. The duration of each session will vary dependent on patient needs but will typically range from 10 to 40 minutes.
Location/Timing: All therapy will be provided to patients with multimorbidity on the acute general medical ward at Frankston Hospital. Therapy will be provided by the allied health assistant following an initial physiotherapy assessment of the patient. The allied health assistant will be delegated provision of routine acute mobility rehabilitation if the patient is transferred to sitting out of bed during the physiotherapy assessment and appropriate for mobilisation (i.e. transfers and walking). This process will involve the physiotherapist completing an initial assessment and providing a handover to the allied health assistant.
Procedures and personalisation: Routine acute mobility rehabilitation of patients with multimorbidity may include any form of skills-based and/or functional strengthening exercise and education, including but not limited to:
1) Mobilisation (i.e. transfers and walking) including progression of gait aid and practice of transfers (e.g. bed to chair)
2) Standing (e.g. squats, heel raises) and seated exercises (e.g. knee extension). The dose and intensity of these exercises will not be specified as the focus is on practicing muscle control for key muscles and joints important for mobilisation (i.e. skills-based).
3) Education on correct use of gait aid, falls risk strategies, correct performance of exercises; provided via verbal conversation
All therapy will be prescribed by the physiotherapist who conducts the initial assessment and tailored to the individual needs of the patient. Therefore, how a patient mobilises (e.g. use of gait aid or no gait aid), the types of exercises they perform, and the intensity of exercises will be prescribed by the physiotherapist and will vary between participants based on their individual needs. All prescribed therapy will be implemented by the allied health assistant. As per standard protocol, following treatment of the patient with multimorbidity the allied health assistant will inform the physiotherapist, who completed the initial assessment, of the details of the session and the patient’s progress in their ability to mobilise. The physiotherapist will use this feedback to determine the discharge plan and re-assess the patient as required.
Fidelity: The fidelity of the intervention will be determined by measuring the time and occasions of service each patient spends with i) the physiotherapist and ii) the allied health assistant.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Name of comparator treatment: Physiotherapist provision of routine acute mobility rehabilitation
Who will deliver the intervention and what is their training: The intervention will be delivered by accredited and practising physiotherapists. Note that this is the only difference between the exposure and comparator groups; all other procedures/protocols are the same.
Mode of delivery: Individual, face-to-face
Dose: One to 5x per week therapy, provided on weekdays, until discharge from acute hospital. Initial physiotherapy assessment may occur on a Saturday. The duration of each session will vary dependent on patient needs but will typically range from 10 to 40 minutes.
Location/Timing: All therapy will be provided to patients with multimorbidity on the acute general medical ward at Frankston Hospital. Therapy will be provided by the physiotherapist following their initial assessment of the patient.
Procedures and Personalisation: Routine acute mobility rehabilitation of patients with multimorbidity may include any form of skills-based and/or functional strengthening exercise and education, including but not limited to:
1) Mobilisation (i.e. transfers and walking) including progression of gait aid and practice of transfers (e.g. bed to chair)
2) Standing (e.g. squats, heel raises) and seated exercises (e.g. knee extension). The dose and intensity of these exercises will not be specified as the focus is on practicing muscle control for key muscles and joints important for mobilisation.
3) Education on correct use of gait aid, falls risk strategies, correct performance of exercises; provided via verbal conversation
All therapy will be tailored to the individual needs of the patient. Therefore, how a patient mobilises (e.g. use of gait aid or no gait aid), the types of exercises they perform, and the intensity of exercises will be prescribed by the physiotherapist and will vary between participants based on their individual needs. Allied health assistants may assist the therapist to mobilise a patient who requires the assistance of two people but will not be delegated the role of providing daily rehabilitation.
Fidelity: The fidelity of the comparator treatment will be determined by measuring the time and occasions of service each patient spends with i) the physiotherapist and ii) the allied health assistant.

Control group

Active

Outcomes

Primary outcome [1]

Feasibility: Demand Domain (Primary Outcome). Demand domain will be evaluated by measuring the recruitment rate (comparing the number of people recruited to the number of eligible participants). This data will be collected prospectively during recruitment by a research assistant who will monitor and record the number of patients who 1) meet the eligibility criteria and 2) participate in the trial.

Timepoint [1]

Time of discharge from acute hospital.

Primary outcome [2]

Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by measuring the amount of time that the physiotherapist spends providing therapy to the patient. This information will be collected using the hospital network electronic medical record system. This information is routinely collected by the system and is recorded in patient medical records. It will be recorded as either 1) direct contact activities (e.g. providing therapy) or 2) indirect contact activities (e.g. typing notes). Direct contact activities and indirect contact activities will be measured as a composite outcome.

Timepoint [2]

Time of discharge from acute hospital

Primary outcome [3]

Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by measuring the amount of time that allied health assistant spends providing therapy to the patient. This information will be collected using the hospital network electronic medical record system. This information is routinely collected by the system and is recorded in patient medical records. It will be recorded as either 1) direct contact activities (e.g. providing therapy) or 2) indirect contact activities (e.g. typing notes). Direct contact activities and indirect contact activities will be measured as a composite outcome.

Timepoint [3]

Time of discharge from acute hospital

Secondary outcome [1]

Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by measuring the number of physiotherapist occasions of service provided to the patient. An occasion of service involves only direct patient activities (i.e. providing therapy). This information will be collected using the hospital network electronic medical record system. This information is routinely collected by the system and is recorded in patient medical records.

Timepoint [1]

Time of discharge from acute hospital.

Secondary outcome [2]

Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by measuring the number of allied health assistant occasions of service provided to the patient. An occasion of service involves only direct patient activities (i.e. providing therapy). This information will be collected using the hospital network electronic medical record system. This information is routinely collected by the system and is recorded in patient medical records.

Timepoint [2]

Time of discharge from acute hospital.

Secondary outcome [3]

Feasibility: Practicality Domain (Primary Outcome). Practicality domain will be evaluated by measuring the cost of acute physiotherapy service. Cost of physiotherapy service will be calculated using the time spent treating and managing patients with multimorbidity and pay rates for physiotherapists and allied health assistants. The time physiotherapists and allied health assistants spend treating patients will be collected from the hospital network electronic medical record system. Pay rates will be obtained from the Victorian Government award rates for physiotherapists and allied health assistants. Costs will include 25% on-costs.

Timepoint [3]

Time of discharge from acute hospital.

Secondary outcome [4]

Feasibility: Practicality Domain (Primary Outcome). Practicality domain will be evaluated by measuring the cost of acute patient care. Cost of acute patient care will be calculated using hospital admission cost data from the health service.

Timepoint [4]

Time of discharge from acute hospital.

Secondary outcome [5]

Feasibility: Practicality Domain (Primary Outcome). Practicality domain will be evaluated by measuring adverse events. Adverse events will include any incident of patient harm that is recorded in the patient medical record. Possible examples of patient harm events include falls and unconscious collapse/vasovagal. Patient harm events will be further classified as ‘not related to the study’, ‘probably not related to the study’, ‘unlikely but possibly related’ or ‘probably related to the study’ by an independent, medical academic. Harm events will also be classified as ‘serious’ or ‘non-serious’.

Timepoint [5]

Time of discharge from acute hospital.

Secondary outcome [6]

Feasibility: Acceptability Domain (Primary Outcome). Acceptability domain will be evaluated by measuring patient satisfaction with physiotherapy care. Patient satisfaction with physiotherapy care will be measured using a modified version of a questionnaire for hospital inpatients receiving inpatient physiotherapy care, whether supervised by a physiotherapist or allied health assistant. The original version of the questionnaire has been validated for use in an inpatient population by Ampiah and colleagues (2019). The patient rates their agreement with each statement on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). For the purpose of this study we will use a modified version with six of the items removed. The items related to financial cost of physiotherapy care, diagnosis, time from physiotherapy referral to assessment, equipment available to the physiotherapist/assistant and compliance with physiotherapy will be removed from the questionnaire.

Timepoint [6]

Time of discharge from acute hospital.

Secondary outcome [7]

Feasibility: Demand Domain (Primary Outcome). Demand domain will be evaluated by conducting in-depth semi-structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi-structured interviews will be conducted one-to-one using an interview guide, and audio-recorded. The interviews will explore their experience with this model of care.

Timepoint [7]

Following cessation of patient participant recruitment and outcome assessment.

Secondary outcome [8]

Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by conducting in-depth semi-structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi-structured interviews will be conducted one-to-one using an interview guide, and audio-recorded. The interviews will explore their experience with this model of care.

Timepoint [8]

Following cessation of patient participant recruitment and outcome assessment.

Secondary outcome [9]

Feasibility: Practicality Domain (Primary Outcome). Practicality domain will be evaluated by conducting in-depth semi-structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi-structured interviews will be conducted one-to-one using an interview guide, and audio-recorded. The interviews will explore their experience with this model of care.

Timepoint [9]

Following cessation of patient participant recruitment and outcome assessment.

Secondary outcome [10]

Feasibility: Acceptability Domain (Primary Outcome). Acceptability domain will be evaluated by conducting in-depth semi-structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi-structured interviews will be conducted one-to-one using an interview guide, and audio-recorded. The interviews will explore their experience with this model of care.

Timepoint [10]

Following cessation of patient participant recruitment and outcome assessment.

Secondary outcome [11]

Daily time spent walking (Secondary Outcome). Daily time in minutes spent walking will be measured using a tri-axial accelerometer-based activity monitor (ActivPAL).

Timepoint [11]

First 7 days after the commencement of rehabilitation from either the allied health assistant or physiotherapist, or until discharge from acute hospital if discharged within 7 days after commencement.

Secondary outcome [12]

Daily steps (Secondary Outcome). Daily steps will be measured using a tri-axial accelerometer-based activity monitor (ActivPAL).

Timepoint [12]

Secondary outcome [13]

Daily time spent sitting or lying (i.e. sedentary behaviour) (Secondary Outcome). Daily time in minutes spent sitting or lying will be measured using a tri-axial accelerometer-based activity monitor (ActivPAL).

Timepoint [13]

Secondary outcome [14]

Daily mobilisation (Secondary Outcome). Daily mobilisation will be measured as the number of days that the patient mobilises (e.g. sits out of bed, walks) during their acute hospital stay and will be audited from patient medical records.

Timepoint [14]

Time of discharge from acute hospital.

Secondary outcome [15]

Reasons for Not Mobilising (Secondary Outcome). Documented reasons for patients not mobilising will be audited from patient medical records. Days on which mobilisation is medically contraindicated will be recorded, ensuring rates of mobilisation reflect only days on which patients were deemed medically suitable for mobilisation. Patients will be contraindicated on any day if one or more of the following complications are experienced:
• Severe pain that restricts mobilisation
• Nausea or vomiting with or without antiemetic
• Vitally unstable: postural blood pressure drop, febrile, bradycardia <40bpm or abnormal heart rhythm
• Disorientated, heavily sedated or difficult to rouse

Timepoint [15]

Time of discharge from acute hospital.

Secondary outcome [16]

Discharge Destination from Acute Hospital (Secondary Outcome). Discharge destination will be selected from the following list of possible destinations: (i) home; (ii) relative/friend’s home; (iii) residential care; (iv) inpatient transition care program, (v) sub-acute rehab/geriatric evaluation management unit. Discharge destination will be collected from patient medical records.

Timepoint [16]

Time of discharge from acute hospital.

Secondary outcome [17]

Falls (Secondary Outcome). The incidence of inpatient falls will be recorded as a composite outcome, where a fall is defined as ‘unintentionally coming to rest on the ground, floor, or other lower level’. Falls will be further classified to reflect the degree of harm; falls that result in either the permanent or temporary loss of function will be classified as an injurious fall, while falls that result in no loss of function will be classified as a non-injurious fall. This data will be collected from patient medical records.

Timepoint [17]

Time of discharge from acute hospital.

Secondary outcome [18]

Patient Functional Activity - Level of Assistance (Secondary Outcome): Patients’ functional activity at discharge will be measured using the Modified Iowa Level of Assistance Scale (mILOA). The mILOA consists of six items and measures the assistance required to achieve functional tasks, including moving from lying to sitting on the edge of the bed; moving from sitting to standing; walking; and negotiating one step. It also measures walking distance and the use of an assistive device.

Timepoint [18]

Time of commencement of rehabilitation from either the allied health assistant or physiotherapist (i.e. baseline) and time of discharge from acute hospital.

Secondary outcome [19]

Length of Acute Hospital Stay (Secondary Outcome). Patient length of acute hospital stay will be measured as the number of days from patient admission to acute hospital to discharge from acute hospital. Length of stay will be collected from patient medical records.

Timepoint [19]

Time of discharge from acute hospital.

Secondary outcome [20]

Discharge Destination From Sub-Acute Hospital (Secondary Outcome). Discharge destination will be selected from the following list of possible destinations: (i) home; (ii) relative/friend’s home; (iii) residential care. Discharge destination will be collected from patient medical records.

Timepoint [20]

Time of discharge from sub-acute hospital.

Secondary outcome [21]

Length of Sub-Acute Hospital Stay (Secondary Outcome). Patient length of sub-acute hospital stay will be measured as the number of days from patient admission to sub-acute hospital to discharge from sub-acute hospital. Length of stay will be collected from patient medical records.

Timepoint [21]

Time of discharge from sub-acute hospital.

Secondary outcome [22]

30-day hospital re-admission (Secondary Outcome). 30-day hospital readmission includes any unplanned readmission within 30 days of discharge from the health service (i.e., readmission from private residence) and will be collected from patient medical records.

Timepoint [22]

30-days following discharge from health service.

Secondary outcome [23]

Cost of Sub-Acute Physiotherapy Service (Secondary Outcome). Cost of physiotherapy service will be calculated using the time spent treating and managing patients with multimorbidity and pay rates for physiotherapists and allied health assistants. The time physiotherapists and allied health assistants spend treating patients will be collected from the hospital network electronic medical record system. Pay rates will be obtained from the Victorian Government award rates for physiotherapists and allied health assistants. Costs will include 25% on-costs.

Timepoint [23]

Time of discharge from sub-acute hospital.

Secondary outcome [24]

Cost of Sub-Acute Patient Care (Secondary Outcome). Cost of sub-acute patient care will be calculated using hospital admission cost data from the health service.

Timepoint [24]

Time of discharge from sub-acute hospital.

Eligibility

Key inclusion criteria

Eligible participants will be patients with multimorbidity who have been admitted to the general medical ward at the participating acute hospital site. Participants must meet the following eligibility criteria:
• Coexistence of two or more chronic conditions, such as cardiovascular disease, diabetes, arthritis, osteoporosis, back pain, respiratory disease (e.g. asthma, chronic obstructive pulmonary disease), arthritis, kidney disease, liver disease, cancer, obesity, and mental health conditions as recorded on the medical record.
• Walked independently prior to admission with or without the use of a walking aid
• Referred to physiotherapy; and on initial assessment physiotherapist prescribes mobility rehabilitation
• Willingness and ability, as determined by initial physiotherapy assessment, to participate in mobility rehabilitation
• Aged 18 years or older
• Able to provide written, informed consent
• Able to communicate in conversational English

Staff participants:
Staff participants for this project include any allied health assistant, physiotherapist or manager involved in the implementation of the allied health assistant model of care. They will include allied health assistant and physiotherapy staff who either i) work on the general medical ward at the acute hospital participating site or ii) have managerial oversight of physiotherapists working on the general medical ward.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patient Participants:
Exclusion criteria are:
• Patients who were non-ambulant OR required assistance of another person to walk pre-admission
• Not referred to physiotherapy; and not prescribed mobility rehabilitation
• Patients not suitable for mobilisation or mobility rehabilitation
• Patients requiring specialist physiotherapy skills to mobilise
• Patients who have undergone major surgery and those admitted with acute stroke

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)

Allocation will be determined by email or phone contact with an independent researcher after the member of the research team has determined eligibility for the study, participants have consented to take part, and baseline assessment has been completed.

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

Participants will be randomly allocated to the experimental (allied health assistant rehabilitation) or control (physiotherapist rehabilitation) group using simple randomisation. Participants will be randomly assigned remotely using simple randomisation design with a computer random number generator prepared by an independent researcher not involved in the screening process, intervention, or collection of data.

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

Quantitative data analysis:
Descriptive statistics will be used to describe the characteristics of the sample by group (means [SD], percentages and frequencies) as well as patient satisfaction, time physiotherapist/allied health assistant spends with patient, cost of physiotherapy service/patient care and adverse events. All analyses will be completed as randomised (i.e. intention to treat analysis).

Physical activity will be measured via patients’ daily average time (in minutes) spent walking. A difference in daily average walking time between groups will be investigated via Poisson or negative binomial regression. Missing data will be managed via multiple imputation, and this feasibility study will help to clarify the extent to which missing data for this outcome presents a problem in analysis. Analyses will be repeated for daily average number of steps and daily average time (in minutes) spent sedentary in lying and sitting.

Adherence to daily mobilisation will be collected in the form of time-to-event data, and mobilisation rate ratios will be calculated using Cox proportional hazards regression to directly compare mobilisation rates in the intervention and control (comparison) conditions. As patients can have multiple mobilisations, and are not eligible for subsequent mobilisation until initial mobilisation has occurred, recurrent event data will be analysed via the Williams and Peterson Gap time survival model, with robust standard errors to account for correlation within patients. In the survival analyses, discharge will be considered a censoring event. This equates to an assumption that data regarding mobilisation on days following discharge are missing at random (given timing of discharge). The appropriateness of this assumption will be checked in sensitivity analyses. No interim analyses will be conducted.

Length of stay will be analysed using survival analysis (time-to-discharge) with death as a competing risk. Functional activity will be analysed using linear regression controlling for baseline scores. Dichotomous outcomes include discharge destination (home vs. residential care), 30-day re-admission (30-day re-admission vs. no re-admission) and faller (fall vs. no falls) will be analysed with logistic regression.

A sub-group analysis is planned to compare results between patients with and without cognitive disorders.

Sample Size Considerations
We aim to recruit 60 participants. While there are no clear guidelines on the sample size required for feasibility studies this size should enable the primary aim of feasibility to be addressed and is comparable to previous evaluations of feasibility trials, including those investigating allied health assistant models of care.

Qualitative data analysis:
Interviews will be audiotaped and records of all interviews will be transcribed. Any identifying information will be removed and each transcript assigned a number for further analysis.

Qualitative analysis of transcripts will be undertaken by two investigators independently, using qualitative data management software. The deidentified transcripts will be read by each investigator and codes devised to represent the data. Codes will be reviewed and emerging themes will be developed inductively through a process of collapsing codes together and defining categories. Consensus between the investigators on the emerging themes and categories will be achieved through discussion. Following the interview, each participant will be sent a copy of their transcript for correction, clarification and further comment, to maximize accuracy of the data (a process termed ‘member checking’). All identifying information in the transcript will be removed following member checking.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/08/2023

Actual

14/08/2023

Date of last participant enrolment

Anticipated

16/04/2024

Actual

19/03/2024

Date of last data collection

Anticipated

28/02/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Peninsula Health

Address [1]

2 Hastings Road Frankston VIC 3199

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Victorian Department of Health

Address [2]

50 Lonsdale St, Melbourne VIC 3000

Country [2]

Australia

Primary sponsor type

Hospital

Name

Peninsula Health

Address

2 Hastings Road Frankston VIC 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

National Centre for Healthy Ageing

Address [1]

2 Hastings Road, Frankston, VIC 3199

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Monash University

Address [2]

Moorooduc Hwy, Frankston VIC 3199

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

La Trobe University

Address [3]

Plenty Road and, Kingsbury Dr, Bundoora VIC 3086

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health Ethics Committee

Ethics committee address [1]

2 Hastings Road Frankston VIC 3199

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/04/2023

Approval date [1]

13/06/2023

Ethics approval number [1]

HREC/97431/PH-2023

Summary

Brief summary

This randomised controlled trial will investigate the feasibility of an allied health assistant providing mobility rehabilitation (i.e. physiotherapy) for patients with multimorbidity in acute hospital. All therapy will be prescribed by a physiotherapist and will include daily walking, and standing and seated exercises. We hypothesise that it is feasible for allied health assistants to provide mobility rehabilitation for patients with multimorbidity in an acute hospital.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Snowdon

Address

Monash University/Peninsula Health 2 Hastings Road VIC 3199

Country

Australia

Phone

+61 3 9788 1722

Fax

[email protected]

Contact person for public queries

Name

David Snowdon

Address

Monash University/Peninsula Health 2 Hastings Road VIC 3199

Country

Australia

Phone

+61 3 9788 1722

Fax

[email protected]

Contact person for scientific queries

Name

David Snowdon

Address

Monash University/Peninsula Health 2 Hastings Road VIC 3199

Country

Australia

Phone

+61 3 9788 1722

Fax

[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?

Individual participant data underlying published results only.

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

Immediately following publication, no end date.

Available to whom?

Anyone who wishes to access it.

Available for what types of analyses?

Any purpose.

How or where can data be obtained?

Unrestricted access via supplementary file of publication.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18983	Study protocol				Study protocol including statistical analysis plan... [More Details]

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Trial Review

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