Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000638639
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
13/10/2005
Date last updated
30/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Day Hospital
Scientific title
Post acute rehabilitation: A randomised controlled trial of day hospital and domiciliary care versus Rehabilitation in the Home for deconditioned patients following hospitalisation to improve functional and nutritional status.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurological injury 766 0
Orthopaedic injury 767 0
Other medical condition requiring rehabilitation. 768 0
Condition category
Condition code
Neurological 842 842 0 0
Other injuries and accidents
Musculoskeletal 843 843 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 844 844 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Day hospital - rehabilitation service provided in hospital 3-5 times per week for a minimum of six weeks. Group 2: RITHOM - rehabilitation services provided in the home for a minimum of twelve sessions.
Intervention code [1] 442 0
None
Comparator / control treatment
Rehabilitation in the Home (RITHOM) - A home-based rehabilitation program delivered by an interdisciplinary team of physiotherapists, occupational therapists, speech therapists, social workers, psychologists, dietitians, nurses, and a rehabilitation medicine physician. Subjects received a minimum of 12 sessions 3 to 5 times a weeks for 4 to 6 weeks with possible extension if required.
Control group
Active

Outcomes
Primary outcome [1] 1081 0
Assessment of Motor and Process Skills
Timepoint [1] 1081 0
At baseline and three months
Primary outcome [2] 1082 0
Bioelectrical impedence
Timepoint [2] 1082 0
At baseline, discharge, and three months.
Secondary outcome [1] 2010 0
Depression
Timepoint [1] 2010 0
At baseline.
Secondary outcome [2] 2011 0
Bloods (albumin, inflammatory markers) and Functional Independence.
Timepoint [2] 2011 0
Measure at baseline and discharge.
Secondary outcome [3] 2012 0
Mini Nutritional Assessment, Assessment of Appetite, bioelectrical impedence, and strength.
Timepoint [3] 2012 0
At baseline, discharge, and three months.
Secondary outcome [4] 2013 0
Mini Mental State Exam, Timed Up and Go, and Short Form 36 (patient and carer).
Timepoint [4] 2013 0
At baseline and three months.
Secondary outcome [5] 2014 0
Patient satisfaction and Carer/Family satisfaction.
Timepoint [5] 2014 0
At discharge.
Secondary outcome [6] 2015 0
Carer Strain Index.
Timepoint [6] 2015 0
At discharge and three months.
Secondary outcome [7] 2016 0
Mortality and place of residence.
Timepoint [7] 2016 0
At three and six months.
Secondary outcome [8] 2017 0
Cost and Readmissions.
Timepoint [8] 2017 0
At six months.

Eligibility
Key inclusion criteria
Patients with either neurological injury, orthopaedic injury, or other medical condition requiring rehabilitation, medically stable, safe and appropriate to return home, requires at least 12 sessions of rehabilitation, sufficient memory and reasoning to participate in rehabilitation, has access to and is able to a use telephone, able to travel in a car for up to one hours two times per day.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If consultant physician decided that RITHOM is definately indicated or Day Hospital is definately contraindicated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque, sealed envelopes that contained the random allocation sequence were created. The group allocation was managed by the centralised randomisation service of the hospital's pharmacy department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random number generator in Microsoft Excel was used to generate the random allocation sequence. Block randomisation was used
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 930 0
Self funded/Unfunded
Name [1] 930 0
Country [1] 930 0
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Department of Rehabilitation and Aged Care Flinders University Repatriation General Hospital Daws Rd Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 789 0
None
Name [1] 789 0
None
Address [1] 789 0
Country [1] 789 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2230 0
Repatriation General Hospital
Ethics committee address [1] 2230 0
Ethics committee country [1] 2230 0
Australia
Date submitted for ethics approval [1] 2230 0
Approval date [1] 2230 0
Ethics approval number [1] 2230 0
Ethics committee name [2] 2231 0
Flinders University/Medical Centre
Ethics committee address [2] 2231 0
Ethics committee country [2] 2231 0
Australia
Date submitted for ethics approval [2] 2231 0
Approval date [2] 2231 0
Ethics approval number [2] 2231 0
Ethics committee name [3] 2232 0
The Royal Adelaide Hospital
Ethics committee address [3] 2232 0
Ethics committee country [3] 2232 0
Australia
Date submitted for ethics approval [3] 2232 0
Approval date [3] 2232 0
Ethics approval number [3] 2232 0

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

Contacts
Principal investigator
Name 36214 0
Address 36214 0
Country 36214 0
Phone 36214 0
Fax 36214 0
Email 36214 0
Contact person for public queries
Name 9631 0
Professor Maria Crotty
Address 9631 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9631 0
Australia
Phone 9631 0
+61 8 82751103
Fax 9631 0
+61 8 82751130
Email 9631 0
[email protected]
Contact person for scientific queries
Name 559 0
Professor Maria Crotty
Address 559 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 559 0
Australia
Phone 559 0
+61 8 82751103
Fax 559 0
+61 8 82751130
Email 559 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMedical day hospital care for older people versus alternative forms of care.2015https://dx.doi.org/10.1002/14651858.CD001730.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.