Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000134628
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
12/08/2005
Date last updated
12/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
In-home preventive health assessment and telephone case management for over 75s living alone in independent living units: A cluster randomised controlled trial.
Scientific title
In-home preventive health assessment and telephone case management for over 75s living alone in independent living units and its effect on health status, health resource utilisation and client satisfaction: A cluster randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General preventive health for elderly 222 0
Condition category
Condition code
Public Health 251 251 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprised of five major elements: 1) targeting before health and/or social crisis, and while community care needs were low; 2) linking clients with a community nurse; 3) comprehensive health assessments and identification of needs; 4) introduction of basic health care and community services and referrals if required; and 5) case management by three-monthly telephone contact. Assessments and case management were performed by experienced community care registered nurses, and case management was performed for a one year period.
Intervention code [1] 156 0
Prevention
Comparator / control treatment
The control group received health assessments and phone calls similar to the experimental group for data collection purposes, and to balance the risk of a Hawthorne effect due to regular contacts with participants. However all aspects of case management were omitted from all episodes of contact with the control group. For ethical reasons control group participants were supplied with a summary of their health assessment results to share with their GP if they wished.
Control group
Active

Outcomes
Primary outcome [1] 295 0
Measures of health perception
Timepoint [1] 295 0
At baseline and after 12 months
Primary outcome [2] 296 0
Measures of functional ability
Timepoint [2] 296 0
At baseline and after 12 months
Primary outcome [3] 297 0
Measures of psychosocial status
Timepoint [3] 297 0
At baseline and after 12 months
Primary outcome [4] 298 0
Measures of health resource utilisation
Timepoint [4] 298 0
Measured after 12 months
Primary outcome [5] 299 0
Measures of mortality
Timepoint [5] 299 0
Measured after 12 months
Primary outcome [6] 300 0
Measures of client satisfaction
Timepoint [6] 300 0
Measured after 12 months
Secondary outcome [1] 660 0
Numbers of previously unidentified needs that were identified during the study, and the case management outcomes of those needs
Timepoint [1] 660 0
Over a 12 month period.

Eligibility
Key inclusion criteria
1) 75 years of age or over 2) living alone 3) able to speak and understand English 4) able to use a telephone in their residence.
Minimum age
75 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) community services related to Activities of Daily Living deficits, such as personal care.2) greater than two community services related to Instrumental Activities of Daily Living deficits 3) significant amounts of informal care (for instance a daughter performing most of the housework).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed - clusters of participants (based on geographical location) were labelled with a geographic location name and written on small sheets of paper. Each paper was folded so identification of the cluster group was not possible, apart from a note identifying the groups as "large" or "small" according to the number of participants the cluster contained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each paper containing a cluster of participants was placed in one of two hats "small" or "large". In this way, sampling was also stratified in order to more evenly balance participant numbers in the exp/cont groups. From each hat, clusters were drawn and assigned consecutively to the experimental or control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomisation was used
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 308 0
University
Name [1] 308 0
Queensland University of Technology
Country [1] 308 0
Australia
Funding source category [2] 309 0
Charities/Societies/Foundations
Name [2] 309 0
Blue Care
Country [2] 309 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 240 0
Charities/Societies/Foundations
Name [1] 240 0
Blue Care
Address [1] 240 0
Country [1] 240 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1180 0
Blue Care and Queensland University of Technology
Ethics committee address [1] 1180 0
Ethics committee country [1] 1180 0
Australia
Date submitted for ethics approval [1] 1180 0
Approval date [1] 1180 0
Ethics approval number [1] 1180 0

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

Contacts
Principal investigator
Name 35973 0
Address 35973 0
Country 35973 0
Phone 35973 0
Fax 35973 0
Email 35973 0
Contact person for public queries
Name 9345 0
Marj Henderson
Address 9345 0
Blue Care - Head Office
56 Sylvan Road
Toowong QLD 4066
Country 9345 0
Australia
Phone 9345 0
+61 7 33773377
Fax 9345 0
Email 9345 0
[email protected]
Contact person for scientific queries
Name 273 0
Marj Henderson
Address 273 0
Blue Care - Head Office
56 Sylvan Road
Toowong QLD 4066
Country 273 0
Australia
Phone 273 0
+61 410 563 652
Fax 273 0
Email 273 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.