Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000205437
Ethics application status
Approved
Date submitted
12/02/2016
Date registered
16/02/2016
Date last updated
16/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Function in the community after inpatient rehabilitation
Scientific title
Function in the community after inpatient rehabilitation in older adults: a cross-sectional study
Secondary ID [1] 288526 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional independence 297616 0
Functional trajectory 297617 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297807 297807 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A cross-sectional observational study design will be used to assess the functional independence of older adults (n=90) living in the community within 12 months of being discharged from inpatient rehabilitation.
Intervention code [1] 293898 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297332 0
The primary outcome will be functional independence. Because there is no consensus on which is the best measure of function in the community, 2 measures will be used and compared; the FIM and the Frenchay Activities Index (FAI).
Timepoint [1] 297332 0
Any time between discharge from inpatient rehabilitation and 12 months following discharge. This will provide a spread of time points to map function over time (compared to function measured as part of routine practice at discharge from inpatient rehabilitation).
Secondary outcome [1] 320747 0
Potential predictors of function will also be assessed.
Personal/ demographic potential predictors such as: age, sex, co-morbidities and diagnosis during rehabilitation (reason for admission to rehabilitation) will be assessed by reviewing participant hospital records and will be confirmed during the patient interview.
Timepoint [1] 320747 0
These factors will be assessed at the same point in time that functional independence is assessed. This will be different for each participant but will be any time between discharge from rehabilitation and 12 months post discharge.
Secondary outcome [2] 320811 0
Rehabilitation length of say (days) will be assessed as a potential predictor of function. Rehabilitation length of stay will be determined by reviewing the participant's hospital records.
Timepoint [2] 320811 0
Rehabilitation length of stay will be determined at the point of discharge from rehabilitation.
Secondary outcome [3] 320812 0
Hospital re-admissions will be assessed by reviewing the participants medical records (for admissions to the same health service) and on patient interview (by asking about hospital presentations to any hospital).
Re-admissions will be recorded as number of re-admissions and total number of overnight stays spent in hospital.
Timepoint [3] 320812 0
Re-admissions will be assessed at the same point in time that functional independence is assessed - any time between discharge from inpatient rehabilitation and 12 months following discharge.
Secondary outcome [4] 320813 0
Functional independence on discharge from rehabilitation will also be assessed as a potential predictor of function in the community.
This is routinely assessed using the FIM at the rehabilitation facilities and recorded in the participants medical record. This outcome will therefore be assessed by reviewing the medical records.
Timepoint [4] 320813 0
Function on discharge from rehabilitation is generally assessed within 24 hours prior to discharge at the rehabilitation facilities.
Secondary outcome [5] 320814 0
Usual physical activity levels will be assessed using the Physical Activity Scale for the Elderly.
Timepoint [5] 320814 0
At the same point in time that functional independence in the community is assessed - any time between discharge from inpatient rehabilitation and 12 months following discharge.
Secondary outcome [6] 320815 0
Falls will be assessed by reviewing hospital records (for falls within hospital) and by asking the participant to recall any falls since they have been discharged home (falls in the home/community).
Timepoint [6] 320815 0
Falls will be assessed at 2 time points: falls during the inpatient rehabilitation period (by assessing medical records for the inpatient stay) and falls in the community (which will be assessed at the same point in time that functional independence is assessed - any time between discharge from inpatient rehabilitation and 12 months following discharge)
Secondary outcome [7] 320816 0
Need for follow up rehabilitation services (e.g allied health services) will be assessed by review of hospital records and by asking the patient if they were referred to, or have needed to see any health professionals related to their rehabilitation stay since being discharged.
Timepoint [7] 320816 0
At the same point in time that functional independence is assessed - any time between discharge from inpatient rehabilitation and 12 months following discharge
Secondary outcome [8] 320817 0
Living situation will be recorded as either: living alone, living with spouse or living with family/others.
Timepoint [8] 320817 0
At the same point in time that functional independence is assessed - any time between discharge from inpatient rehabilitation and 12 months following discharge.

Eligibility
Key inclusion criteria
To be eligible for inclusion participants need to be: community-dwelling, English speaking older adults (65years or older) who have received inpatient rehabilitation for any health condition at the health service within the previous 12 months
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Older adults will not be eligible if they live in high or low level residential care as we are focusing on functional independence that allows older adults to remain living independently in the community.
People with cognitive impairment (as assessed by a score of more than 2 errors on the Short Portable Mental Status Questionnaire) will not be eligible to participate as they will not be able to take part in the questionnaire process (which relies on recall).

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Functional status (FIM and FAI) of participants will be plotted against time post rehabilitation.
Percentage of participants obtaining the highest or lowest possible scores on the FIM and FAI will be calculated to assess for floor and ceiling effects.
Multiple regression analysis will be used to assess the ability of a set of personal (age, sex, rehabilitation diagnosis, co-morbidity), rehabilitation (length of stay, falls during rehabilitation and FIM at discharge) and community (living situation, physical activity levels, falls in the community, hospital re-admissions and need for follow-up therapy) factors to predict function in the community. Using the equation: n > 50+8m, where m is the number of independent contributing factors, our estimated sample size is n=90, with a maximum of 5 independent factors per analysis (as there are 5 potential predictors in the community factors).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/02/2016
Actual
11/04/2016
Date of last participant enrolment
Anticipated
30/09/2017
Actual
10/10/2017
Date of last data collection
Anticipated
Actual
10/10/2017
Sample size
Target
90
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5266 0
Broadmeadows Health Service - Broadmeadows
Recruitment hospital [2] 5267 0
Bundoora Extended Care Centre - Bundoora
Recruitment postcode(s) [1] 12728 0
3047 - Broadmeadows
Recruitment postcode(s) [2] 12729 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 292875 0
University
Name [1] 292875 0
La Trobe University
Country [1] 292875 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Melbourne, Victoria, Australia 3086
Country
Australia
Secondary sponsor category [1] 291619 0
None
Name [1] 291619 0
Nil
Address [1] 291619 0
N/A
Country [1] 291619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294378 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 294378 0
Ethics committee country [1] 294378 0
Australia
Date submitted for ethics approval [1] 294378 0
08/10/2015
Approval date [1] 294378 0
08/12/2015
Ethics approval number [1] 294378 0
HREC/15/NH/43
Ethics committee name [2] 294379 0
La Trobe University Human Research Ethics Committee
Ethics committee address [2] 294379 0
Ethics committee country [2] 294379 0
Australia
Date submitted for ethics approval [2] 294379 0
21/12/2015
Approval date [2] 294379 0
13/01/2016
Ethics approval number [2] 294379 0
HREC/15/NH/43

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

Contacts
Principal investigator
Name 63494 0
Dr Casey Peiris
Address 63494 0
La Trobe University, Melbourne, Victoria, Australia 3086
Country 63494 0
Australia
Phone 63494 0
+613 94795931
Fax 63494 0
Email 63494 0
[email protected]
Contact person for public queries
Name 63495 0
Casey Peiris
Address 63495 0
La Trobe University, Melbourne, Victoria, Australia 3086
Country 63495 0
Australia
Phone 63495 0
+613 94795931
Fax 63495 0
Email 63495 0
[email protected]
Contact person for scientific queries
Name 63496 0
Casey Peiris
Address 63496 0
La Trobe University, Melbourne, Victoria, Australia 3086
Country 63496 0
Australia
Phone 63496 0
+613 94795931
Fax 63496 0
Email 63496 0
[email protected]

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
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Documents added automatically
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