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Trial registered on ANZCTR


Registration number
ACTRN12609000648224
Ethics application status
Approved
Date submitted
1/03/2008
Date registered
31/07/2009
Date last updated
10/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying older people to prevent disability: the Brief Risk Identification Geriatric Health Tool trial (BRIGHT)
Scientific title
Does a case finding process using the Brief Risk Identification Geritaric Health Tool (BRIGHT) tool in primary care prevent development and progression of disabiltiy in people aged 75 and over living in the community.
Secondary ID [1] 287851 0
ni known
Universal Trial Number (UTN)
Trial acronym
the BRIGHT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospitalisation of those aged 75+ living in the community 2898 0
residential care placement of those aged 75+ living in the community 243395 0
quality of life as measured by the World Health Organisation Quality of Life brief form (WHO QoL-Bref) of those aged 75+ living in the community 243405 0
Condition category
Condition code
Public Health 3033 3033 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In primary care the BRIGHT tool, an 11 item self completion postal questionnaire is sent to all those aged 75 and older on thier birthday from their primary care practitioner. Active recall ensures completion. Those scoring over 3 on the tool are referred for geriatric services through a coordinated comprehensive community assessment and referral programme already available. They will receive the BRIGHT tool every year for 3 years.
Intervention code [1] 293232 0
Prevention
Comparator / control treatment
control practice patients get usual care for three years. This involves usual general practice services and referral to geriatric medicine and support services on an ad hoc opportunistic basis
Control group
Active

Outcomes
Primary outcome [1] 3913 0
Hospitalisation rate measured by National statistical data
Timepoint [1] 3913 0
18 months, 3 years
Primary outcome [2] 3914 0
residential care placement, routinely collected data
Timepoint [2] 3914 0
18 months 3 years
Secondary outcome [1] 6588 0
Quality of Life, World Health Organisation brief Quality of Life Intrument (WHOQoL-bref)
Timepoint [1] 6588 0
baseline, 18 months, 3 years
Secondary outcome [2] 8941 0
physical function measured by Nottingham extended activities of daily living scale
Timepoint [2] 8941 0
baseline, 18 months, 3 years

Eligibility
Key inclusion criteria
community living, 75 years and older for non-Maori, 65 years and older for Maori participants.
Minimum age
75 Years
Maximum age
120 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
living in residential care

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)
cluster allocation of enrolled practices involved contacting the holder of the allocation schedule (using computer generated randomisation schedule) who was "off-site" at central research centre, after all patients of practices had been recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
'computer generated randomisation schedule. Stratified allocation. by practice type, Maori provider, mainstream provider. And block randomised within the 3 sites of the trial
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
cluster randomised trial, practices were randomised to intervention or control.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 810 0
New Zealand
State/province [1] 810 0
Bay of Plenty District Health Board, Tauranga,
Country [2] 811 0
New Zealand
State/province [2] 811 0
Canterbury DHB, Christchurch

Funding & Sponsors
Funding source category [1] 4398 0
Government body
Name [1] 4398 0
Health Research Council of New Zealand
Address [1] 4398 0
Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
Country [1] 4398 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland,
Park Avenue, Grafton
Auckland
Country
New Zealand
Secondary sponsor category [1] 2825 0
None
Name [1] 2825 0
Address [1] 2825 0
Country [1] 2825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6447 0
Multi-regional Ethic Comittee
Ethics committee address [1] 6447 0
Emalene Pearson

Postal address:
PO Box 5013
Wellington

Courier address:
Level 2
1-3 The Terrace
Wellington

Telephone: (04) 470 0655
Fax: (04) 496 2191
Email: multiregion_ethicscommittee@moh.govt.nz
Ethics committee country [1] 6447 0
New Zealand
Date submitted for ethics approval [1] 6447 0
Approval date [1] 6447 0
01/03/2008
Ethics approval number [1] 6447 0
MEC Reference: MEC/06/10/136

Summary
Brief summary
The BRIGHT trial aims to see whether health surveillance for older people using a birthday card with a brief functional survey sent by the General Ppractitioner (GP) will reduce development and worsening of disability. Three regions of New Zealand, Christchurch, Wellington and Tauranga will contribute patients and follow up will be for three years.
Trial website
Trial related presentations / publications
14. Ngaire Kerse, Michal Boyd, Chris McLean, Jane Koziol-McLain, Gillian Robb, Utility of a primary health care case finding tool to identify older people with disability, the BRIGHT tool. Age and Ageing 2008:37;553-558.
Public notes

Contacts
Principal investigator
Name 28418 0
Prof Ngaire Kerse
Address 28418 0
SOPH
Univesrity of AUckland,
Private Bag 92019
Auckland
New Zealand 1001
Country 28418 0
New Zealand
Phone 28418 0
64 9 9234467
Fax 28418 0
Email 28418 0
n.kerse@auckland.ac.nz
Contact person for public queries
Name 11575 0
Ms Chris McLean
Address 11575 0
Department of General Practice and Primary Health Care, School of Population Health, Building 730, Level 2, Tamaki Campus
261 Morrin Road, Glen Innes
University of Auckland, Private Bag 92019, Auckland
Country 11575 0
New Zealand
Phone 11575 0
64 9 3737599 ext 82584
Fax 11575 0
Email 11575 0
c.mclean@auckland.ac.nz
Contact person for scientific queries
Name 2503 0
Prof Ngaire Kerse
Address 2503 0
Department of General Practice and Primary Health Care, School of Population Health, Building 730, Level 2, Tamaki Campus
261 Morrin Road, Glen Innes
University of Auckland, Private Bag 92019, Auckland
Country 2503 0
New Zealand
Phone 2503 0
64 9 3737599 ext 84467
Fax 2503 0
Email 2503 0
n.kerse@auckland.ac.nz

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