Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001050246
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
25/06/2018
Date last updated
30/11/2023
Date data sharing statement initially provided
20/08/2019
Date results information initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of health-related quality of life at admission and discharge from the Rehabilitation In The Home service
Scientific title
Measurement of health-related quality of life at admission and discharge from the Rehabilitation In The Home service
Secondary ID [1] 295225 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 308377 0
Joint arthroplasty 308378 0
Condition category
Condition code
Musculoskeletal 307373 307373 0 0
Other muscular and skeletal disorders
Neurological 307374 307374 0 0
Other neurological disorders
Injuries and Accidents 307434 307434 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The interventions provided by a multidisciplinary team as part of the Rehabilitation In The Home service will not change from that usually provided. The service is designed to replace part of a hospital stay with therapy in the home. Eligible patients are assessed and assisted by a multidisciplinary team to work toward their goals following a deterioration in functional ability, either due to illness or injury. The average duration of the service for any one person is two weeks.
Intervention code [1] 301561 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306345 0
EQ-5D-5L which is a standardised instrument to measure health-related quality of life.
Timepoint [1] 306345 0
Start and end of Rehabilitation In The Home service.
Secondary outcome [1] 348234 0
Functional Independence Measure
Timepoint [1] 348234 0
Start and end of Rehabilitation In The Home service

Eligibility
Key inclusion criteria
Referred to the Central Adelaide Local Health Network Rehabilitation In The Home service..
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to communicate effectively and easily in English (e.g. insufficient understanding of English, head injury, cognitive impairment, psychiatric condition).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Raw data will be collected on a purpose-designed form and subsequently entered onto an Excel spreadsheet by one of the investigators. Data will be imported into SPSS for analysis. Whilst there are no data on which to undertake a formal sample size calculation, it is anticipated that at least 50 patients should be recruited to and complete the study over a period of approximately 12 months, This sample size should be sufficient to enable meaningful analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2018
Actual
2/07/2018
Date of last participant enrolment
Anticipated
30/06/2019
Actual
19/01/2019
Date of last data collection
Anticipated
31/07/2019
Actual
31/01/2019
Sample size
Target
50
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11171 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 11172 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 11173 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 22998 0
5000 - Adelaide
Recruitment postcode(s) [2] 22999 0
5011 - Woodville
Recruitment postcode(s) [3] 23000 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 299816 0
Hospital
Name [1] 299816 0
The Queen Elizabeth Hospital
Country [1] 299816 0
Australia
Primary sponsor type
Individual
Name
Shelley Fulton
Address
Rehabilitation In The Home, L7 Main Building, The Queen Elizabeth Hospital, Woodville Road, Woodville, South Australia 5011
Country
Australia
Secondary sponsor category [1] 299168 0
Individual
Name [1] 299168 0
Kathy Stiller
Address [1] 299168 0
7F-060 Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000
Country [1] 299168 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300695 0
Central Adelaide Local Health Network Research Ethics Committee
Ethics committee address [1] 300695 0
Level 3, Roma Mitchell House, 136 North Terrace, Adelaide, South Australia 5000
Ethics committee country [1] 300695 0
Australia
Date submitted for ethics approval [1] 300695 0
05/06/2018
Approval date [1] 300695 0
07/06/2018
Ethics approval number [1] 300695 0
HREC/18/CALHN/323

Summary
Brief summary
The purpose of this study is to investigate whether rehabilitation in the home services improve health-related quality of life. There has been little research evaluating whether health-related quality of life improves as a result of rehabilitation in the home programs (or similar). Measures of functional status at the start and end of rehabilitation in the home programs do not necessarily show change as these measures are not sufficiently sensitive or responsive over the relatively short duration of a rehabilitation in the home program. We believe measuring health-related quality of life may be a useful tool for evaluating the effectiveness of rehabilitation in the home program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84506 0
Mr Shelley Fulton
Address 84506 0
Rehabilitation In The Home, L7 Main Building, The Queen Elizabeth Hospital, Woodville Road, Woodville, South Australia 5011
Country 84506 0
Australia
Phone 84506 0
+61 8 82228660
Fax 84506 0
Email 84506 0
Shelley.Fulton@sa.gov.au
Contact person for public queries
Name 84507 0
Mr Shelley Fulton
Address 84507 0
Rehabilitation In The Home, L7 Main Building, The Queen Elizabeth Hospital, Woodville Road, Woodville, South Australia 5011
Country 84507 0
Australia
Phone 84507 0
+61 8 82228660
Fax 84507 0
Email 84507 0
Shelley.Fulton@sa.gov.au
Contact person for scientific queries
Name 84508 0
Dr Kathy Stiller
Address 84508 0
7F-060, Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country 84508 0
Australia
Phone 84508 0
+61 8 70742639
Fax 84508 0
Email 84508 0
Kathy.Stiller@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Fulton S, Dunk P, Stiller K. Health-related qualit... [More Details]

Documents added automatically
No additional documents have been identified.