Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000568617
Ethics application status
Approved
Date submitted
30/09/2005
Date registered
30/09/2005
Date last updated
30/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of an assessment and care planning protocol for frail elderly patients in acute care
Scientific title
Impact of an assessment and care planning protocol for frail elderly patients in acute care
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 694 0
Condition category
Condition code
Other 769 769 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comprehensive geriatric assessment and inpatient follow-up. The intervention was offered throughout the initial patient episode until discharge from hospital.
Intervention code [1] 689 0
Early detection / Screening
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 980 0
Days in hospital over 6 months from date of entry
Timepoint [1] 980 0
Secondary outcome [1] 1852 0
Readmissions to hospital
Timepoint [1] 1852 0
Secondary outcome [2] 1853 0
Placement in residential care
Timepoint [2] 1853 0
Secondary outcome [3] 1854 0
Functional status
Timepoint [3] 1854 0
At discharge and 28 days post discharge

Eligibility
Key inclusion criteria
Acute medical admission; expected to stay > 48 hours; meets 2 of a suite of additional "frailty" criteria.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque sequentially numbered envelopes. Opened envelopes were annotated with time and date opened, and filed in the patients trial paperwork to allow monitoring of correct sequence use
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients randomised to intervention and control groups using stratified permuted blocks. The random allocation sequence generated using the statistical software SPIDA. Stratification based on hospital site, treating physician and whether the patient already known to the physician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 850 0
Government body
Name [1] 850 0
NDHP4
Country [1] 850 0
Australia
Funding source category [2] 851 0
Charities/Societies/Foundations
Name [2] 851 0
Utah Foundation
Country [2] 851 0
United States of America
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 718 0
Government body
Name [1] 718 0
NDHP4;
Address [1] 718 0
Country [1] 718 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2114 0
University of Queensland
Ethics committee address [1] 2114 0
Ethics committee country [1] 2114 0
Australia
Date submitted for ethics approval [1] 2114 0
Approval date [1] 2114 0
Ethics approval number [1] 2114 0
Ethics committee name [2] 2115 0
The Mater Hospital Brisbane
Ethics committee address [2] 2115 0
Ethics committee country [2] 2115 0
Australia
Date submitted for ethics approval [2] 2115 0
Approval date [2] 2115 0
Ethics approval number [2] 2115 0
Ethics committee name [3] 2116 0
Townsville General Hospital
Ethics committee address [3] 2116 0
Ethics committee country [3] 2116 0
Australia
Date submitted for ethics approval [3] 2116 0
Approval date [3] 2116 0
Ethics approval number [3] 2116 0

Summary
Brief summary
The efficacy of a multi-disciplinary consultative service offered to selected "frail" general medical patients, recruited at admission, is tested using an RCT design. The primary outcome is the ability of the intervention to reduce use of institutional care (hospital and residential care) over a 6 month period from the date of entry.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35778 0
Address 35778 0
Country 35778 0
Phone 35778 0
Fax 35778 0
Email 35778 0
Contact person for public queries
Name 9878 0
Professor Len Gray
Address 9878 0
Academic Unit in Geriatric Medicine
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Brisbane QLD 4102
Country 9878 0
Australia
Phone 9878 0
+61 7 32405327
Fax 9878 0
+61 7 32405399
Email 9878 0
[email protected]
Contact person for scientific queries
Name 806 0
Professor Len Gray
Address 806 0
Academic Unit in Geriatric Medicine
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Brisbane QLD 4102
Country 806 0
Australia
Phone 806 0
+61 7 32405327
Fax 806 0
+61 7 32405399
Email 806 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
No additional documents have been identified.