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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)
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)
Secondary ID [1] 289558 0
Nil known
Universal Trial Number (UTN)
U1111-1184-7614
Trial acronym
The PAAD Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General Medical admission
Hospital discharge 299281 0
Physical Activity 299282 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299279 299279 0 0
Physiotherapy
Public Health 301148 301148 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
7
Target follow-up type
Days
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
Intervention code [1] 295150 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298767 0
Discharge destination
Timepoint [1] 298767 0
At discharge from General Medical bed card
Secondary outcome [1] 325143 0
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"
Timepoint [1] 325143 0
7 days post consenting patients (consenting to completed at initial physiotherapy initial contact) or at hospital discharge, whichever comes first
Secondary outcome [2] 325144 0
Step Count. This will be measured by the accelerometers.
Timepoint [2] 325144 0
7 days post consenting patients (consenting to completed at initial physiotherapy initial contact) or at hospital discharge, whichever comes first
Secondary outcome [3] 325146 0
Sleep duration. Sleep duration will be measured in hours by the accelerometers
Timepoint [3] 325146 0
7 days post consenting patients (consenting to completed at initial physiotherapy initial contact) or at hospital discharge, whichever comes first
Secondary outcome [4] 325147 0
Physical Activity Scale in the Elderly (PASE) Scores
Timepoint [4] 325147 0
Measured at Physiotherapy initial contact for the 7 day period prior to coming in to hospital

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2017
Actual
17/01/2017
Date of last participant enrolment
Anticipated
23/06/2017
Actual
15/08/2017
Date of last data collection
Anticipated
30/06/2017
Actual
22/08/2017
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6029 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 13479 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 293927 0
Hospital
Name [1] 293927 0
Melbourne Health Mary Elizabeth Watson Early Career Fellowship in Allied Health
Country [1] 293927 0
Australia
Primary sponsor type
Individual
Name
Aruska D'Souza
Address
Royal Melbourne Hospital
300 Grattan St
Parkville 3050
Victoria
Country
Australia
Secondary sponsor category [1] 292753 0
None
Name [1] 292753 0
Address [1] 292753 0
Country [1] 292753 0
Other collaborator category [1] 279052 0
University
Name [1] 279052 0
University of Melbourne
Address [1] 279052 0
Royal Parade
Parkville, Victoria 3050
Country [1] 279052 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295345 0
Melbourne Health Human Research Ethics Committee (EC00243)
Ethics committee address [1] 295345 0
Ethics committee country [1] 295345 0
Australia
Date submitted for ethics approval [1] 295345 0
29/06/2016
Approval date [1] 295345 0
24/08/2016
Ethics approval number [1] 295345 0
2016.152
Ethics committee name [2] 295346 0
University of Melbourne Central Health Research Ethics Committee (EC00248)
Ethics committee address [2] 295346 0
Ethics committee country [2] 295346 0
Australia
Date submitted for ethics approval [2] 295346 0
27/06/2016
Approval date [2] 295346 0
24/08/2016
Ethics approval number [2] 295346 0

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

Contacts
Principal investigator
Name 66966 0
Miss Aruska D'Souza
Address 66966 0
Royal Melbourne Hospital
Level 4North - Allied Health
300 Grattan St
Parkville, 3050
Victoria
Country 66966 0
Australia
Phone 66966 0
+613 9342 7000
Fax 66966 0
Email 66966 0
aruska.d'souza@mh.org.au
Contact person for public queries
Name 66967 0
Aruska D'Souza
Address 66967 0
Royal Melbourne Hospital
Level 4North - Allied Health
300 Grattan St
Parkville, 3050
Victoria
Country 66967 0
Australia
Phone 66967 0
+613 9342 7000
Fax 66967 0
Email 66967 0
aruska.d'souza@mh.org.au
Contact person for scientific queries
Name 66968 0
Aruska D'Souza
Address 66968 0
Royal Melbourne Hospital
Level 4North - Allied Health
300 Grattan St
Parkville, 3050
Victoria
Country 66968 0
Australia
Phone 66968 0
+613 9342 7000
Fax 66968 0
Email 66968 0
aruska.d'souza@mh.org.au

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
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