Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000140651
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
12/08/2005
Date last updated
29/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of Services Promoting Independence and Recovery in Elders
Scientific title
case-managed community-based health services that aim to allow an older person to remain living in the community despite increasing frailty compared to usual care (existing community-based services that are not case-managed).
Universal Trial Number (UTN)
Trial acronym
ASPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty and Independence in Older People 230 0
Condition category
Condition code
Public Health 261 261 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Case-managed community-based health services that aim to allow an older person to remain living in the community despite increasing frailty.
Intervention code [1] 145 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 306 0
Institutional-free (residential care placement) survival
Timepoint [1] 306 0
After 24 months.
Secondary outcome [1] 680 0
Minimum Date Set-Home Care (MDS-HC)
Timepoint [1] 680 0
Secondary outcome [2] 681 0
Health related quality of life
Timepoint [2] 681 0
Secondary outcome [3] 682 0
Social support
Timepoint [3] 682 0
Secondary outcome [4] 683 0
Caregiver burden
Timepoint [4] 683 0
Secondary outcome [5] 684 0
Cost-effectiveness
Timepoint [5] 684 0
At 24Mths.

Eligibility
Key inclusion criteria
Male and female aged 65 yrs or older (55 years if Maori with age related condition); health and disability needs level (high or very high).
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to home based care, residential care indicated.

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)
Randomisation will be concealed using a central computer randomisation service within the Clinical Trials Research Unit, The University of Auckland.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation with minimisation is conducted using a JAVA-based tailor-made computer software programme. The minimisation factors are age, health and disability needs level, gender, living alone or with others.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/11/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment outside Australia
Country [1] 135 0
New Zealand
State/province [1] 135 0

Funding & Sponsors
Funding source category [1] 316 0
Government body
Name [1] 316 0
Ministry of Health, New Zealand Government
Country [1] 316 0
New Zealand
Primary sponsor type
Government body
Name
Ministry of Health, New Zealand Government
Address
Country
New Zealand
Secondary sponsor category [1] 246 0
None
Name [1] 246 0
None
Address [1] 246 0
Country [1] 246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1202 0
Hamilton
Ethics committee address [1] 1202 0
Ethics committee country [1] 1202 0
New Zealand
Date submitted for ethics approval [1] 1202 0
Approval date [1] 1202 0
Ethics approval number [1] 1202 0
Ethics committee name [2] 1203 0
Wellington
Ethics committee address [2] 1203 0
Ethics committee country [2] 1203 0
New Zealand
Date submitted for ethics approval [2] 1203 0
Approval date [2] 1203 0
Ethics approval number [2] 1203 0
Ethics committee name [3] 1204 0
Christchurch
Ethics committee address [3] 1204 0
Ethics committee country [3] 1204 0
New Zealand
Date submitted for ethics approval [3] 1204 0
Approval date [3] 1204 0
Ethics approval number [3] 1204 0

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

Contacts
Principal investigator
Name 35185 0
Address 35185 0
Country 35185 0
Phone 35185 0
Fax 35185 0
Email 35185 0
Contact person for public queries
Name 9334 0
Hugh Senior
Address 9334 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland 1
Country 9334 0
New Zealand
Phone 9334 0
+64 9 3737999
Fax 9334 0
+64 9 3731710
Email 9334 0
[email protected]
Contact person for scientific queries
Name 262 0
Hugh Senior
Address 262 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland 1
Country 262 0
New Zealand
Phone 262 0
+64 9 3737999
Fax 262 0
+64 9 3731710
Email 262 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.