Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000042549
Ethics application status
Approved
Date submitted
24/01/2006
Date registered
27/01/2006
Date last updated
27/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Tauranga Older Persons Comprehensive Assessment Trial
Scientific title
A randomised phase III study evaluating the effectiveness and cost utility of the Minimum Dataset- Home Care (MDS-HC) assessment tool in comparison to the existing Needs and Service Coordination (NASC) assessment process to improve the quality of life for older people in the community requiring these assessment services.
Universal Trial Number (UTN)
Trial acronym
TOPCAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older people in the community 1004 0
Condition category
Condition code
Public Health 1080 1080 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group receive an assessment using the Minimum Dataset-Home Care (MDS-HC) assessment tool. Both intervention and control groups then have their needs identified from the results of the assessments followed by the development of care plans and services. The intervention and control (the assessment) is a one-off event, with follow-up interviews at one, four and twelve months.
Intervention code [1] 862 0
Other interventions
Comparator / control treatment
The control group receive a standard Needs and Service Coordination assessment.
Control group
Active

Outcomes
Primary outcome [1] 1445 0
Health related quality of life, as assessed by the SF36
Timepoint [1] 1445 0
Collected at baseline, one, four and twelve months
Secondary outcome [1] 2564 0
1.Functional ability (via the Barthel Index and the Nottingham EADL)
Timepoint [1] 2564 0
Collected at baseline, one, four and twelve months.
Secondary outcome [2] 2565 0
2.Number of hospitalisations
Timepoint [2] 2565 0
Collected at baseline, one, four and twelve months.
Secondary outcome [3] 2566 0
3.Attendance at Emergency Department (ED)
Timepoint [3] 2566 0
Collected at baseline, one, four and twelve months.
Secondary outcome [4] 2567 0
4.Home care service usage
Timepoint [4] 2567 0
Collected at baseline, one, four and twelve months.
Secondary outcome [5] 2568 0
5.Care management plan implemented
Timepoint [5] 2568 0
Collected at baseline, one, four and twelve months.
Secondary outcome [6] 2569 0
6.Community services usage (district nursing, therapy, social work, befriending etc)
Timepoint [6] 2569 0
Collected at baseline, one, four and twelve months.
Secondary outcome [7] 2570 0
7.Number of GP visits
Timepoint [7] 2570 0
Collected at baseline, one, four and twelve months.
Secondary outcome [8] 2571 0
8.Health related quality of life (EuroQoL)
Timepoint [8] 2571 0
Collected at baseline, one, four and twelve months.
Secondary outcome [9] 2572 0
9.Social Support (via the Duke Social Support Index)
Timepoint [9] 2572 0
Collected at baseline, one, four and twelve months.
Secondary outcome [10] 2573 0
10.Cognitive Status (via the AMTS questionnaires)
Timepoint [10] 2573 0
Collected at baseline, one, four and twelve months.
Secondary outcome [11] 2574 0
11.Geriatric Depression Scale (GDS-15)
Timepoint [11] 2574 0
Collected at baseline, one, four and twelve months.

Eligibility
Key inclusion criteria
1.Males and females aged 65 or greater years on the day of baseline examination; or aged 55 if of Mäori or Pacific Ethnicity and eligible for NASC/ OPAT services.2.All participants must be eligible for assessment by the three designated MDS-HC assessors.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Those clients with a terminal illness and are currently receiving palliative care services2.Participants directly transferred from hospital to permanent residential care after the initial assessment.

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 accessed by a freephone connection. The service is provided by a private company experienced in IVR technology and randomisation processes for clinical trials.
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, Barthel score, gender, living alone or with others.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment outside Australia
Country [1] 263 0
New Zealand
State/province [1] 263 0

Funding & Sponsors
Funding source category [1] 1183 0
Government body
Name [1] 1183 0
Ministry of Health, New Zealand
Country [1] 1183 0
New Zealand
Primary sponsor type
Government body
Name
Ministry of Health, New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 1042 0
None
Name [1] 1042 0
none
Address [1] 1042 0
Country [1] 1042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2501 0
Bay of Plenty DHB, part of the Northern Y Ethics Committee jurisdiction
Ethics committee address [1] 2501 0
Ethics committee country [1] 2501 0
New Zealand
Date submitted for ethics approval [1] 2501 0
Approval date [1] 2501 0
Ethics approval number [1] 2501 0

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

Contacts
Principal investigator
Name 35410 0
Address 35410 0
Country 35410 0
Phone 35410 0
Fax 35410 0
Email 35410 0
Contact person for public queries
Name 10051 0
Theo Brandt
Address 10051 0
School of Nursing
University of Auckland
Private Bag 92019
Auckland
Country 10051 0
New Zealand
Phone 10051 0
+64 9 3737599 ext. 82245
Fax 10051 0
+64 9 3677158
Email 10051 0
[email protected]
Contact person for scientific queries
Name 979 0
Theo Brandt
Address 979 0
School of Nursing
University of Auckland
Private Bag 92019
Auckland
Country 979 0
New Zealand
Phone 979 0
+64 9 3737599 ext. 82245
Fax 979 0
+64 9 3677158
Email 979 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.