Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000049673
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
26/07/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
DEPS-GP
Scientific title
Cluster-randomised trial of general practitioners to evaluate the effects of education versus no specific education about depression and self-harm behaviour in later life.
Universal Trial Number (UTN)
Trial acronym
DEPS-GP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide completion and attempt 120 0
Condition category
Condition code
Neurological 135 135 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Education of general practitioners
Intervention code [1] 58 0
Prevention
Comparator / control treatment
No specific education
Control group
Active

Outcomes
Primary outcome [1] 171 0
Suicide completion or attempt
Timepoint [1] 171 0
Secondary outcome [1] 374 0
Depression
Timepoint [1] 374 0
Secondary outcome [2] 375 0
Quality of life
Timepoint [2] 375 0
Secondary outcome [3] 376 0
Suicide ideation
Timepoint [3] 376 0

Eligibility
Key inclusion criteria
Practicing Australian GPs and their older patients
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Planning to move practice over the next 2 years, (2) less than 20 older patients in the practice, (3) NES consultations only.

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)
Randomisation organised and maintained centrally by colleague not directly involved with the running of the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation (GP is the centre of cluster). Blocks. Random numbers generated by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 186 0
Government body
Name [1] 186 0
National Health and Medical Research Council
Country [1] 186 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 139 0
None
Name [1] 139 0
None
Address [1] 139 0
Country [1] 139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 951 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 951 0
Ethics committee country [1] 951 0
Australia
Date submitted for ethics approval [1] 951 0
Approval date [1] 951 0
Ethics approval number [1] 951 0

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

Contacts
Principal investigator
Name 35136 0
Address 35136 0
Country 35136 0
Phone 35136 0
Fax 35136 0
Email 35136 0
Contact person for public queries
Name 9247 0
Prof. Osvaldo P. Almeida
Address 9247 0
Unit of Geriatric Psychiatry
University of Western Australia
M573
35 Stirling Highway
Crawley WA 6009
Country 9247 0
Australia
Phone 9247 0
+61 8 92242855
Fax 9247 0
+61 8 92248009
Email 9247 0
osvalm@cyllene.uwa.edu.au
Contact person for scientific queries
Name 175 0
Prof. Osvaldo P. Almeida
Address 175 0
Unit of Geriatric Psychiatry
University of Western Australia
M573
35 Stirling Highway
Crawley WA 6009
Country 175 0
Australia
Phone 175 0
+61 8 92242855
Fax 175 0
+61 8 92248009
Email 175 0
osvalm@cyllene.uwa.edu.au

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.