Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001158853
Ethics application status
Approved
Date submitted
25/10/2012
Date registered
1/11/2012
Date last updated
2/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying depression following a diagnosis of acute coronary syndrome: testing the predictive validity of a depression risk assessment questionnaire
Scientific title
Is it possible to identify patients who are at risk of developing depression following an acute coronary syndrome event by using a depression risk assessment questionnire?
Secondary ID [1] 281442 0
Nil
Universal Trial Number (UTN)
U1111-1136-3619
Trial acronym
DepACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Identifying those patients 'at risk' of developing depression following a diagnosis of acute coronary syndrome (ACS) 287700 0
Condition category
Condition code
Mental Health 288039 288039 0 0
Depression
Cardiovascular 288040 288040 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of patients for depressive symptoms following an acute coronary syndrome event over a 4 month period. Participants will be contacted by telephone at 2 months and 4 months and asked the questions contained in the Patient Health Questionnaire-9.
Intervention code [1] 285947 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288246 0
Depressive symptoms as measured by the Patient Health Questionnaire 9 (PHQ-9) score > 5
Timepoint [1] 288246 0
at T2, (2 months ACS post event) and T3 (4 months post ACS event
Secondary outcome [1] 299688 0
Nil
Timepoint [1] 299688 0
Nil

Eligibility
Key inclusion criteria
Admitted to hospital with diagnosis of unstable angina or non ST elevated myocardial infarction or ST elevated myocardial infarction. Able to give informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English Speaking; unable to read the questionnaires; unable to give informed consent, have suspected impaired cognitive function or head injury likely to affect informed consent.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286208 0
Charities/Societies/Foundations
Name [1] 286208 0
Ray Florence Shaw Award
Country [1] 286208 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave.,
Nedlands
WA 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 285018 0
None
Name [1] 285018 0
Nil
Address [1] 285018 0
Nil
Country [1] 285018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288283 0
Human Research Ethics Committee
Ethics committee address [1] 288283 0
Ethics committee country [1] 288283 0
Australia
Date submitted for ethics approval [1] 288283 0
Approval date [1] 288283 0
03/05/2012
Ethics approval number [1] 288283 0
HREC 2012-059

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

Contacts
Principal investigator
Name 34875 0
Address 34875 0
Country 34875 0
Phone 34875 0
Fax 34875 0
Email 34875 0
Contact person for public queries
Name 18122 0
Ms Jo Crittenden
Address 18122 0
Heart Research Institute
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
WA 6009
Country 18122 0
Australia
Phone 18122 0
+61 8 93464301
Fax 18122 0
Email 18122 0
[email protected]
Contact person for scientific queries
Name 9050 0
Ms Jo Crittenden
Address 9050 0
Heart Research Institute
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
WA 6009
Country 9050 0
Australia
Phone 9050 0
+61 8 93464301
Fax 9050 0
Email 9050 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.