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
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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
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

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Cluster randomisation was used
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 1180 0
Approval date [1] 1180 0
Ethics approval number [1] 1180 0

Brief summary
The study followed the health outcomes of 124 Independent Living Unit residents aged 75 years or over and living alone to see if health assessments and early basic interventions had an impact on their health and well being. If required, interventions included health information, specialist referrals, and home help. Residents were linked to a community nurse, who provided low intensity case management by phone every three months. Half of the participants participated in the early intervention experimental model, while the remainder received their usual community care. At the end of the 12 month study period, those involved in the experiment had a higher level of satisfaction with community care, but more time was needed to see if there were other detectable health outcomes. We found previously unidentified needs among 66% of the experimental group, and throughout the course of the study most of those needs were resolved. However, no other benefits from the program were detected after one year in terms of health perception, functional ability, psychosocial status, health resource utilisation and mortality. This was consistent with many other similar studies.
Trial website
Trial related presentations / publications
Public notes

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
Phone 9345 0
+61 7 33773377
Fax 9345 0
Email 9345 0
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
Phone 273 0
+61 410 563 652
Fax 273 0
Email 273 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary