Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000638437
Ethics application status
Approved
Date submitted
7/12/2007
Date registered
13/12/2007
Date last updated
18/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Coaching Older Adults and their Carers to have their preferences Heard (COACH): A Randomised Controlled Trial in Transition Care
Scientific title
Quality of care for older adults exiting a residential Transition Care program as assessed by the Care Transition Measure (CTM-15) at 3 months: An intervention to enhance patient and carer involvement versus usual care.
Secondary ID [1] 251699 0
90/07
Universal Trial Number (UTN)
Trial acronym
COACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of care for older adults exiting a residential Transition Care Program. 2610 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2728 2728 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient and carer met with a geriatrician approximately 2 weeks following admission. A Question Prompt List (QPL) and audiotape were utilised as information strategies. An experienced aged care nurse met with the patient and carer pre-discharge to review and update the care plan and check patient and/or carer understanding of medications. The nurse also initiated telephone contact in the first month post discharge. Recruitment commenced in May 2008 and was completed in March 2010. The sample size was increased in June 2009 to provide greater statistical power to detect differences in health resource utilisation (a secondary outcome measure). There is a 12 month follow-up of patients and carers. Final analysis will be undertaken from June 2011.
Intervention code [1] 2349 0
Other interventions
Comparator / control treatment
Usual care, as defined by the Australian Government Department of Health and Ageing Transition Care Program Guidelines
Control group
Active

Outcomes
Primary outcome [1] 3621 0
Care Transition Measure (CTM-15)
Timepoint [1] 3621 0
3 months following entry to the residential Transition Care program
Secondary outcome [1] 6062 0
Unplanned days in hospital and residential aged care
Timepoint [1] 6062 0
12 months following entry to the residential Transition Care Program

Eligibility
Key inclusion criteria
Admission to a single residential transition care setting during the recruitment period (Feb 2008-Feb 2009). Presence of an informal (unpaid carer) who consents to participate in the study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are unable to communicate in English. Carers will be excluded if they are unable to read and understand written English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes held by a Clinical Trials Pharmacist at Repatriation General Hospital
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 514 0
5063

Funding & Sponsors
Funding source category [1] 2869 0
Government body
Name [1] 2869 0
National Health and Medical Research Council
Country [1] 2869 0
Australia
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daws Road
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 2586 0
None
Name [1] 2586 0
Address [1] 2586 0
Country [1] 2586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4808 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 4808 0
Ethics committee country [1] 4808 0
Australia
Date submitted for ethics approval [1] 4808 0
26/11/2007
Approval date [1] 4808 0
18/02/2008
Ethics approval number [1] 4808 0

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

Contacts
Principal investigator
Name 28233 0
Address 28233 0
Country 28233 0
Phone 28233 0
Fax 28233 0
Email 28233 0
Contact person for public queries
Name 11390 0
Stacey Masters
Address 11390 0
Department of Rehabilitation and Aged Care
Daws Road
Daw Park SA 5041
Country 11390 0
Australia
Phone 11390 0
+61 8 82751103
Fax 11390 0
+61 8 82751130
Email 11390 0
stacey.masters@flinders.edu.au
Contact person for scientific queries
Name 2318 0
Professor Maria Crotty
Address 2318 0
Department of Rehabilitation and Aged Care
Daws Road
Daw Park SA 5041
Country 2318 0
Australia
Phone 2318 0
+61 8 82751103
Fax 2318 0
+61 8 82751130
Email 2318 0
stacey.masters@flinders.edu.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
SourceTitleYear of PublicationDOI
EmbaseCosts and advance directives at the end of life: a case of the 'Coaching Older Adults and Carers to have their preferences Heard (COACH)' trial.2015https://dx.doi.org/10.1186/s12913-015-1201-9
EmbaseInfluence of health locus of control on recovery of function in recently hospitalized frail older adults.2015https://dx.doi.org/10.1111/ggi.12281
N.B. These documents automatically identified may not have been verified by the study sponsor.