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Trial registered on ANZCTR
Registration number
ACTRN12617000026325
Ethics application status
Approved
Date submitted
15/12/2016
Date registered
9/01/2017
Date last updated
14/12/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Association between Physical Activity levels and Acute hospital Discharge destination in patients referred to physiotherapy and admitted under General Medical units at the Royal Melbourne Hospital (The PAAD Study)
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Scientific title
Association between Physical Activity levels and Acute hospital Discharge destination in patients referred to physiotherapy and admitted under General Medical units at the Royal Melbourne Hospital (The PAAD Study)
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Secondary ID [1]
289558
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Nil known
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Universal Trial Number (UTN)
U1111-1184-7614
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Trial acronym
The PAAD Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
General Medical admission
Hospital discharge
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Physical Activity
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Condition category
Condition code
Physical Medicine / Rehabilitation
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0
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Physiotherapy
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Public Health
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0
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Health service research
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
7
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Target follow-up type
Days
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Description of intervention(s) / exposure
Patients referred to Physiotherapy and admitted under a General Medical bed card and at the Royal Melbourne Hospital will be prospectively screened for inclusion into this study. The following data will be collected on 50 patients:
Patient Demographics
- Date of Birth
- Gender
- Weight
- Height
- Language spoken
- Principle diagnosis
- Co-morbidities
Pre-hospital physical activity level:
The Physical Activity Scale for the Elderly - a brief, valid and reliable questionnaire will be used to measure physical activity levels in the seven days prior to hospital admission.
In hospital physical activity level
Physical activity levels will be measured using accelerometers called Sensewear MF devices. Accelerometers will be worn from time of consenting (on day of initial physiotherapy contact) until day of discharge or 7 days from time first worn (whichever comes first).
- Sedentary Activity– defined as an accelerometer output of 0-1.5 METs
- Activity – where an accelerometer output of 1.51-3.0 METs is defined as “Low level activity”, 3.1-4.5 METs as “moderate” and >4.5 METs as “vigorous”
- Step count
- Metabolic equivalents (METs)
- Energy expenditure
- Sleep duration
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Intervention code [1]
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Discharge destination
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Assessment method [1]
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Timepoint [1]
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At discharge from General Medical bed card
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Secondary outcome [1]
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Activity Levels and Energy Expenditure (Sedentary, low, moderate and vigorous). This will be measured by the accelerometers. Where accelerometer output of 1.5-3.0 METs is defined as "Low level activity; 3.1-4.5 METs as "moderate" and >4.5 as "vigorous"
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Assessment method [1]
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Timepoint [1]
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7 days post consenting patients (consenting to completed at initial physiotherapy initial contact) or at hospital discharge, whichever comes first
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Secondary outcome [2]
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Step Count. This will be measured by the accelerometers.
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Assessment method [2]
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Timepoint [2]
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7 days post consenting patients (consenting to completed at initial physiotherapy initial contact) or at hospital discharge, whichever comes first
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Secondary outcome [3]
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Sleep duration. Sleep duration will be measured in hours by the accelerometers
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Assessment method [3]
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Timepoint [3]
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7 days post consenting patients (consenting to completed at initial physiotherapy initial contact) or at hospital discharge, whichever comes first
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Secondary outcome [4]
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Physical Activity Scale in the Elderly (PASE) Scores
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Assessment method [4]
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Timepoint [4]
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Measured at Physiotherapy initial contact for the 7 day period prior to coming in to hospital
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Eligibility
Key inclusion criteria
- Patients referred to Physiotherapy and admitted under General Medical units on the General Medical wards at the Royal Melbourne Hospital (5 South East and 5 South West).
- Patients under a General Medical bed card but requiring ICU will be eligible once they are discharged to the General Medical wards as this is where discharge planning would typically commence.
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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
- Patients who are for palliation
- Patients already recruited who are readmitted
- Patients less than 18 years of age
- Patients transferred from other units (including the Acute Medical and Short Stay Units) and who have already had Physiotherapy intervention will not be included.
- Patients under General Medical unit who are admitted under a different ward (“outliers”). This study requires the use of devices that may be unfamiliar to nursing staff which may reduce compliance. Staff working on the Medical Wards will receive basic training on these devices.
- Similarly, patients who have had their initial Physiotherapy contact on the weekend or public holidays will not be included (including those patients transferred from ICU and seen on the ward on the weekend or public holiday). Patients admitted on the weekend or public holiday who have not had any physiotherapy intervention will remain appropriate to be included.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
Descriptive statistics will be used to summarize demographic and clinical characteristics and outcome data including physical activity levels before admission and after admission Correlations will be used to assess the bivariate relationship between physical activity levels (both before and after admission) and other variables including patient demographics (age, gender), body mass index (kg/m2) cognition, mobility, function, falls, and length of stay.
Predictive utility of the measures will be assessed using regression analyses to predict discharge destination
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/01/2017
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Actual
17/01/2017
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Date of last participant enrolment
Anticipated
23/06/2017
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Actual
15/08/2017
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Date of last data collection
Anticipated
30/06/2017
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Actual
22/08/2017
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment postcode(s) [1]
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3050 - Royal Melbourne Hospital
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Melbourne Health Mary Elizabeth Watson Early Career Fellowship in Allied Health
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Address [1]
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Royal Melbourne Hospital
300 Grattan St
Parkville 3050
Victoria
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Aruska D'Souza
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Address
Royal Melbourne Hospital
300 Grattan St
Parkville 3050
Victoria
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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University
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Name [1]
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University of Melbourne
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Address [1]
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Royal Parade
Parkville, Victoria 3050
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Melbourne Health Human Research Ethics Committee (EC00243)
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Ethics committee address [1]
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Royal Melbourne Hospital
300 Grattan St
Parkville 3050
Victoria
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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29/06/2016
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Approval date [1]
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24/08/2016
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Ethics approval number [1]
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2016.152
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Ethics committee name [2]
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University of Melbourne Central Health Research Ethics Committee (EC00248)
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Ethics committee address [2]
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University of Melbourne
Royal Parade
Parkville, 3010
Victoria
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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27/06/2016
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Approval date [2]
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24/08/2016
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Ethics approval number [2]
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Summary
Brief summary
Medical patients often present to hospital with both medical and functional problems, including social dependency, reduced mobility and cognitive impairment. As such, discharge planning forms an important part of a patient's hospital stay. At present, an allied health team - consisting mainly of physiotherapist, occupational therapists, social workers, dieticians and speech pathologists - make recommendations for discharge destination based on clinical experience. If the patient is not for discharge home, the treating medical team makes a referral to the Consultant Liaison Rehabilitation and Aged Care team for a Geriatrician opinion. This process is potentially problematic when clinicians disagree on discharge destination. This can delay discharge and increase the patient's length of hospital stay. It can also detrimentally impact on the patient and family experience.
We hypothesise that one factor effecting discharge destination may be physical activity levels, that is, patients who are less physically active prior to their admission and patients who are less physically active on the ward during an admission are more likely to need further subacute intervention on discharge from the acute setting. Thus, this study aims to investigate if pre-admission physical activity levels and / or in hospital physical activity levels are associated with discharge destination.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Aruska D'Souza
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Address
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Royal Melbourne Hospital
Level 4North - Allied Health
300 Grattan St
Parkville, 3050
Victoria
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Country
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Australia
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Phone
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+613 9342 7000
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Fax
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Email
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aruska.d'
[email protected]
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Contact person for public queries
Name
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Miss Aruska D'Souza
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Address
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Royal Melbourne Hospital
Level 4North - Allied Health
300 Grattan St
Parkville, 3050
Victoria
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Country
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Australia
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Phone
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+613 9342 7000
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Fax
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Email
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aruska.d'
[email protected]
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Contact person for scientific queries
Name
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Miss Aruska D'Souza
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Address
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Royal Melbourne Hospital
Level 4North - Allied Health
300 Grattan St
Parkville, 3050
Victoria
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Country
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Australia
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Phone
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+613 9342 7000
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Fax
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Email
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aruska.d'
[email protected]
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No information has been provided regarding IPD availability
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.
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