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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12608000027314
Ethics application status
Approved
Date submitted
9/01/2008
Date registered
18/01/2008
Date last updated
18/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Examination of the effect of a designated client centred goal facilitation tool on service provision, quality of life and independence among older people
Scientific title
Examination of the effect of a designated client centred goal facilitation tool on service provision, quality of life and independence among older people
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older people with disability 2682 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2804 2804 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Examination of the effect of a designated goal facilitation tool on services provided to older people receiving home based support services in South Auckland. The tool is used as part of the Needs Assessment undertaken by Needs Assessment Service Coordinators (NASC). The clients goal then forms the basis for developing the package of home based support. These packages are reviewed at 3 and 6 months post-implementation. The primary and secondary outcomes will be assessed at 6 months.
Intervention code [1] 2424 0
Rehabilitation
Comparator / control treatment
Usual care. This consists of the development of a home support package based on the findings of a standard needs assessment undertaken by NASC
Control group
Active

Outcomes
Primary outcome [1] 3692 0
'Short Form - 36 (SF-36)'
Timepoint [1] 3692 0
baseline and 6 months
Secondary outcome [1] 6308 0
Dukes Social Support Scale
Timepoint [1] 6308 0
Baseline and 6 months
Secondary outcome [2] 6309 0
Short Physical Performance Battery
Timepoint [2] 6309 0
Baseline and 6 months
Secondary outcome [3] 6310 0
Proactive Coping Scale
Timepoint [3] 6310 0
Baseline and 6 months

Eligibility
Key inclusion criteria
A new referral to Counties Manukau District Health Board Needs Assessment Service Coordination (NASC) for home based support services
Aged over 65 years (55 if
Maori or Pacific Island)
>7/10 MSQ
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged under 65. Referred to NASC for short term support, carer support or placement in aged residential 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 725 0
New Zealand
State/province [1] 725 0

Funding & Sponsors
Funding source category [1] 2940 0
Government body
Name [1] 2940 0
Health Research Council of New Zealand
Country [1] 2940 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
School of Nursing
ECOM House
Ferncroft St
Private Bag 92019
Country
New Zealand
Secondary sponsor category [1] 2654 0
None
Name [1] 2654 0
Address [1] 2654 0
Country [1] 2654 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study will assess the impact of a designated goal facilitation on service provision and clinical outcomes among older Pakeha (65+) or Mäori (55+) referred for home based support in South Auckland. Service provision will be assessed by interviewing Needs Assessment Service Coordination staff and home based support service providers. The following outcomes will also be examined across the two groups of participants at 6 months post randomisation: Quality of life measured by SF-36; Physical function measured by short Physical Performance Battery; Social participation measured by Dukes Social Support Questionnaire; Caregiver stress measured by caregiver Reaction Assessment; Levels of engagement and motivation of the older participants by the Proactive Coping Scale
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28280 0
Address 28280 0
Country 28280 0
Phone 28280 0
Fax 28280 0
Email 28280 0
Contact person for public queries
Name 11437 0
John Parsons
Address 11437 0
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
Country 11437 0
Niue
Phone 11437 0
021 532 980
Fax 11437 0
Email 11437 0
[email protected]
Contact person for scientific queries
Name 2365 0
John Parsons
Address 2365 0
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
Country 2365 0
New Zealand
Phone 2365 0
021 532 980
Fax 2365 0
Email 2365 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.