Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000708651
Ethics application status
Approved
Date submitted
31/10/2005
Date registered
2/11/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Care coordination pilot trial
Scientific title
Pilot trial of care coordination in chronic disease of the elderly in order to improve quality of life.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic disease in the elderly. 858 0
Condition category
Condition code
Other 924 924 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Care coordination to improve management of elderly veterans. The intervention will be trialled for 12 months. The control group will receive usual care.
Intervention code [1] 744 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1210 0
Quality of life
Timepoint [1] 1210 0
Measured at baseline and at 12 months
Secondary outcome [1] 2207 0
User satisfaction and cost of care
Timepoint [1] 2207 0
Measured at baseline and at 12 months.

Eligibility
Key inclusion criteria
Prescribed at least five PBS-approved medications; chronic disease.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not end-stage palliative care.

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 at the University of Queensland
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a computer-generated pseudo-random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants and assessors will be blinded; those administering the intervention cannot be
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1019 0
Government body
Name [1] 1019 0
DVA
Country [1] 1019 0
Australia
Primary sponsor type
Government body
Name
DVA
Address
Country
Australia
Secondary sponsor category [1] 883 0
University
Name [1] 883 0
University of Queensland
Address [1] 883 0
Country [1] 883 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35559 0
Address 35559 0
Country 35559 0
Phone 35559 0
Fax 35559 0
Email 35559 0
Contact person for public queries
Name 9933 0
Dr Michael Kortt
Address 9933 0
Director
Health Research and Development
Department of Veterans' Affairs
PO Box 21
Canberra ACT 2606
Country 9933 0
Australia
Phone 9933 0
+61 2 62896537
Fax 9933 0
+61 2 62894776
Email 9933 0
[email protected]
Contact person for scientific queries
Name 861 0
Professor Richard Wootton
Address 861 0
Centre for Online Health
Royal Children's Hospital
Level 3
Foundation Building
Herston QLD 4029
Country 861 0
Australia
Phone 861 0
+61 7 33464754
Fax 861 0
+61 7 33464705
Email 861 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.