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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03737409
Registration number
NCT03737409
Ethics application status
Date submitted
18/09/2018
Date registered
9/11/2018
Titles & IDs
Public title
PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial
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Scientific title
PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial
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Secondary ID [1]
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HREC/18/Alfred/42
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Universal Trial Number (UTN)
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Trial acronym
PFOX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fibrotic Interstitial Lung Disease
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Ambulatory Oxygen Therapy
Other interventions - Sham Ambulatory Oxygen Therapy
Experimental: Oxygen therapy with POC (AOT group) - Patients will receive ambulatory oxygen therapy provided by a portable oxygen concentrator and will be encouraged to use it at all times when they are moving about, including walking at home or in the community, during exercise or during other activities.
Sham comparator: Sham oxygen therapy with POC (air group) - Patients will receive sham ambulatory oxygen therapy provided by a portable oxygen concentrator and will be encouraged to use it at all times when they are moving about, including walking at home or in the community, during exercise or during other activities.
Other interventions: Ambulatory Oxygen Therapy
Supplemental oxygen delivered during exercise and activities of daily living via a portable oxygen concentrator
Other interventions: Sham Ambulatory Oxygen Therapy
Air delivered during exercise and activities of daily living via a portable oxygen concentrator that has been modified to deliver air
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in physical activity measured by steps per day
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Assessment method [1]
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Steps per day assessed by activity monitors
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Timepoint [1]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [1]
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Change in functional exercise capacity assessed by 6-minute walk distance
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Assessment method [1]
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Distance in meters achieved on a 6-minute walk test
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Timepoint [1]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [2]
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Change in health related quality of life evaluated using the St George's Respiratory Questionnaire
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Assessment method [2]
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St George's Respiratory Questionnaire is a disease-specific health related quality of life questionnaire.The questionnaire is divided in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impact (social functioning and psychological disturbances resulting from airways disease). Values of each domain as well as the total score value will be reported. Each item is weighted based on empirical data. Total score and scores in each domain can range from 0 to 100. Higher scores indicate more limitations in quality of life.
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Timepoint [2]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [3]
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Change in dyspnea measured using the Dyspnea-12 questionnaire
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Assessment method [3]
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Dyspnea-12 is a uni-dimensional 12-item questionnaire divided in 2 domains: physical items (1 to 7) and affective items (8-12). Each item evaluate breathing experience and can be scored as: None (0), Mild (1), Moderate (2) or Severe (3). Results of this questionnaire will be reported as total score that can range from 0 to 36 and separate scores that can range from 0 to 21 for physical component and 0 to 15 for affective component. Higher scores indicate worse dyspnea.
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Timepoint [3]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [4]
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Changes in fatigue evaluated by the Fatigue Severity Scale
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Assessment method [4]
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Fatigue Severity Scale (FSS), a self reported rating scale including 9 items to measure how fatigue affects motivation, exercise, physical functioning, carrying out duties and how fatigue interferes with work, family, or social life. Each item is scored on a 7 point scale in which 1 = strongly disagree and 7= strongly agree. Total score range from 9 to 63. Higher scores indicate greater fatigue severity.
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Timepoint [4]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [5]
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Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
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Assessment method [5]
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Hospital Anxiety and Depression Scale (HADS), a scale with 14 items divided into two domains : anxiety symptoms (7 items) and depression symptoms (7 items). Each item can be scored from 0 to 3. Scores from each domain can vary from 0 to 21 and are stratified as follows: 0-7 (indicates absence of anxiety/depression symptoms); 8-10 ( presence of symptoms of anxiety and depression in moderate degree - borderline); 11 or more (significant number of anxiety/depression symptoms - confirmed cases). Score of each domain as well as number of confirmed cases will be reported.
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Timepoint [5]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [6]
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Change in time spent in moderate to vigorous physical activity
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Assessment method [6]
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Time spent in moderate to vigorous physical activity, measured by a wrist-worn, tri-axial accelerometer.
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Timepoint [6]
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Baseline assessment, 3 month and 6 month assessments
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Secondary outcome [7]
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Change in sedentary time
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Assessment method [7]
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Time spent sedentary, measured by a wrist-worn, tri-axial accelerometer.
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Timepoint [7]
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Baseline assessment, 3 month and 6 month assessments
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Secondary outcome [8]
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Skeletal muscle metabolism
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Assessment method [8]
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Plasma markers of skeletal muscle metabolism (xanthine, hypoxanthine \[units pmole/µL\]) will be analysed from collected blood samples.
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Timepoint [8]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [9]
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Systemic inflammation
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Assessment method [9]
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C-reactive protein \[unit ng/mL\]) will be analysed from collected blood samples.
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Timepoint [9]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [10]
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Oxidative stress
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Assessment method [10]
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Thiobarbituric acid reactive substrates \[units µM\]) will be analysed from collected blood samples.
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Timepoint [10]
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Baseline, 3 month and 6 month assessments
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Secondary outcome [11]
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Use of oxygen therapy
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Assessment method [11]
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Hours of usage of the portable concentrator.
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Timepoint [11]
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3 month and 6 month assessments
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Secondary outcome [12]
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Oxygen saturation in daily life
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Assessment method [12]
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Wrist oximeter that will be worn during waking hours on two consecutive weekdays.
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Timepoint [12]
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3 month and 6 month assessments
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Secondary outcome [13]
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Incremental cost-effectiveness ratio
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Assessment method [13]
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Difference in health care costs compared to differences in quality-adjusted life years -QALYs
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Timepoint [13]
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6 month assessment
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Eligibility
Key inclusion criteria
* Confirmed diagnosis of Fibrotic Interstitial Lung Disease
* Stable pharmacotherapy over the last 3 months
* Exertional desaturation (SpO2=88% for at least 10 consecutive seconds) during a 6 Minute Walking Test performed on room air
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Currently using or eligible for long term oxygen therapy (PaO2=55 mmHg at rest on room air, or 56-59 mmHg with evidence of right heart failure)
* Current smokers
* Pregnant patients
* Patients cognitively unable to consent; or if death or transplant is anticipated within the study period.
* Participants currently in pulmonary rehabilitation
* Non-ambulant patients
* Admission to an acute care hospital within the last 30 days
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2024
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Actual
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Sample size
Target
260
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash University - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The fibrotic interstitial lung diseases (fILD) are characterised by lung scarring, distressing breathlessness and poor health-related quality of life. Exertional desaturation (low blood oxygen during exercise) is a hallmark of fILD, occurring in over 50% of patients. It is sometimes treated with ambulatory oxygen therapy (AOT), which involves breathing supplemental oxygen during physical activity. However the absence of clinical trials has given rise to marked variations in policy and practice globally. Even where AOT is available, treatment adherence using the traditional delivery method of cylinder gas is poor. Recently new devices called portable oxygen concentrators (POCs), have become available, which are lighter and more maneuverable than a cylinder. This may enhance adherence and maximize treatment benefits. This trial will determine the clinical benefits and societal costs of AOT for people with fILD and exertional desaturation. A randomised controlled trial with blinding of participants, assessors and clinicians, and an embedded economic evaluation will be conducted. A total of 260 participants with fILD and exertional desaturation will be randomly assigned to use either AOT or air delivered using a POC for 6 months. If this trial demonstrates clinical and economic benefits of AOT then the findings can be rapidly translated into practice.
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Trial website
https://clinicaltrials.gov/study/NCT03737409
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Trial related presentations / publications
Holland AE, Corte T, Chambers DC, Palmer AJ, Ekstrom MP, Glaspole I, Goh NSL, Hepworth G, Khor YH, Hoffman M, Vlahos R, Skold M, Dowman L, Troy LK, Prasad JD, Walsh J, McDonald CF. Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial. BMJ Open. 2020 Dec 13;10(12):e040798. doi: 10.1136/bmjopen-2020-040798.
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Public notes
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Contacts
Principal investigator
Name
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Anne Holland, Professor
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Anne Holland, Professor
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Address
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Country
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Phone
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+61 3 99030214
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data will be available after deidentification of participants after publication, with approval of the Alfred Health Human Research Ethics Committee.
Supporting document/s available: Study protocol
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When will data be available (start and end dates)?
9-36 months after article publication
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Available to whom?
Proposals submitted to corresponding author and approved by Alfred Hospital Human Research Ethics Committee.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/09/NCT03737409/SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03737409