Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000256572
Ethics application status
Approved
Date submitted
23/06/2006
Date registered
27/06/2006
Date last updated
21/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Home based services for older people: exploring a new approach
Scientific title
A cluster randomised control trial to compare the effects of a restorative home based model versus usual care to improve wellbeing for community dwelling older people
Secondary ID [1] 252044 0
Nil
Secondary ID [2] 252046 0
Nil
Secondary ID [3] 252061 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional impairment 1233 0
Condition category
Condition code
Public Health 1317 1317 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A trained co-ordinator undertakes an assessment and sets goals with each individual older person.
Support workers receive specialised training in relation to the older person achieving their goals.

The duration of the intervention will be over one year with follow-ups assessed at four and seven months.
Intervention code [1] 1162 0
Other interventions
Comparator / control treatment
The control group continue to receive usual care.
Control group
Active

Outcomes
Primary outcome [1] 1800 0
The primary outcome was change in health related quality of life measured by the Short Form 36 Health Survey.
Timepoint [1] 1800 0
Measured at baseline, four and seven months
Primary outcome [2] 1801 0
Older peoples physical, mental, and social wellbeing were measured using standardised scale measurements. Specifically, the following were assessed: functional mobility (measured by the Nottingham Extended Activities of Daily Living questionnaire and the Timed Up and Go test); sense of control (measured by the Mastery scale); and social support network (measured by the Duke Social Support Index).
Timepoint [2] 1801 0
Measured at baseline, four and seven months
Secondary outcome [1] 3158 0
Focus groups were held with support workers to ascertain their opinions of the service.
Timepoint [1] 3158 0
Measured at baseline and fourteen months
Secondary outcome [2] 3159 0
Informal carer stress was assessed with the Carer Reaction Assessment.
Timepoint [2] 3159 0
Measured at baseline, four and seven months.
Secondary outcome [3] 3160 0
Coordinator perceptions were established via one-on-one interviews.
Timepoint [3] 3160 0
Measured at 14 months.
Secondary outcome [4] 264621 0
A basic comparison of costs for the two groups was undertaken
Timepoint [4] 264621 0
Measured at 14 months.

Eligibility
Key inclusion criteria
Older people who received assistance from the home care agency
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Older people or support workers who have or who are currently recovering from a serious illness/injury, which could be physical or mental, will be excluded from the study.

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)
Cluster randomisation method is used. Ten clusters of approximately 20 older people are determined. These clusters are then randomly assigned to intervention or control groups. Eighty percent of the older people within one cluster are chosen for participation. Thus allowing for each older person within a cluster to have equal chance of being chosen for participation. This also allows for a 25% refusal rate. This is to be undertaken by a researcher otherwise not involved with participants and data will be held by this researcher at a separate site. The outcome assessor will remain blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomised lists
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
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 360 0
New Zealand
State/province [1] 360 0

Funding & Sponsors
Funding source category [1] 1442 0
University
Name [1] 1442 0
The University of Auckland
Country [1] 1442 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 1276 0
None
Name [1] 1276 0
Nil
Address [1] 1276 0
Country [1] 1276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2817 0
The University of Auckland Human Participant Ethics Committee
Ethics committee address [1] 2817 0
The University of Auckland, Auckland
Ethics committee country [1] 2817 0
New Zealand
Date submitted for ethics approval [1] 2817 0
Approval date [1] 2817 0
20/04/2005
Ethics approval number [1] 2817 0
2005/087

Summary
Brief summary
Currently home-based services in New Zealand have a number of issues and are failing to provide appropriate and reliable services for older people. They are based on a dependency model and have a standardised rigid focus with defined responses to the identified needs of elderly. In response to these issues, restorative home care aims to improve flexibility of service delivery to meet the needs of older people living at home. For this research study, the restorative service will be implemented and compared to the current usual care for older people living at home using a randomised control trial research design. It is hoped that the restorative treatment group will have improved physical, psychological and social wellbeing when compared to usual care for older people living at home. Outcome data will be collected at baseline, four and seven months
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35174 0
Address 35174 0
Country 35174 0
Phone 35174 0
Fax 35174 0
Email 35174 0
Contact person for public queries
Name 10351 0
Anna King
Address 10351 0
The School of Nursing
The University of Auckland
PO Box 92019
Auckland
Country 10351 0
New Zealand
Phone 10351 0
+64 9 373 7599 ext 82153
Fax 10351 0
Email 10351 0
[email protected]
Contact person for scientific queries
Name 1279 0
Anna King
Address 1279 0
The School of Nursing
The University of Auckland
PO Box 92019
Auckland
Country 1279 0
New Zealand
Phone 1279 0
+64 9 373 7599 ext 82153
Fax 1279 0
Email 1279 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
SourceTitleYear of PublicationDOI
Dimensions AIA restorative home care intervention in New Zealand: perceptions of paid caregivers2011https://doi.org/10.1111/j.1365-2524.2011.01020.x
N.B. These documents automatically identified may not have been verified by the study sponsor.