Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000789662
Ethics application status
Approved
Date submitted
12/12/2005
Date registered
14/12/2005
Date last updated
14/12/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Post Discharge Care for High-Risk Psychiatric Patients
Scientific title
Post Discharge Care for High Risk Psychiatric Patients: A randomised control trial to evaluate the impact of Intensive Case Management as an Aftercare Intervention in Suicide Attempters Following Discharge from Inpatient Settings to prevent repetition of suicidal behaviour.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide attempts
psychiatric 949 0
Condition category
Condition code
Mental Health 1018 1018 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are assigned the Intensive Case Management (ICM) group who will receive the proposed service. Participants in both the ICM (intervention) and TAU (control) groups are to be assessed at 6-month intervals (immediately following discharge, and at 6 and 12 months). The Project will run for 21 months. However, timing of Project phases will vary depending on the timing of discharge for participants.
Intervention code [1] 796 0
Treatment: Other
Comparator / control treatment
Participants are assigned to the Treatment As Usual (TAU) group who will be discharged in the usual way.
Control group
Active

Outcomes
Primary outcome [1] 1365 0
Assessments cover the following indicators: Psychopathology, Suicidality, Depression, Hopelessness, Anxiety, Impulsiveness, Reasons for Living, Quality of Life, Global Functioning, Ability to Access Services, and Client Satisfaction.
Following the conclusion of assessments, the Intensive Case Management and Treatment As Usual groups will be compared on the above indicators, to determine whether intensive case management resulted in a reduction of suicide risk
Timepoint [1] 1365 0
These will be measured at 6 and 12 months
Secondary outcome [1] 2417 0
Improvements in life function
Timepoint [1] 2417 0
Measured at 6 and 12 months.

Eligibility
Key inclusion criteria
History of suicide attempts and psychiatric illness are recruited at discharge from psychiatric inpatient setting at the Gold Coast Hospital.
Minimum age
18 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple alternate allocation (one/one)
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
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1120 0
Government body
Name [1] 1120 0
Department of Health and Ageing
Country [1] 1120 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 978 0
Government body
Name [1] 978 0
QLD Health
Address [1] 978 0
Country [1] 978 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35402 0
Address 35402 0
Country 35402 0
Phone 35402 0
Fax 35402 0
Email 35402 0
Contact person for public queries
Name 9985 0
Dr Marianne Wyder
Address 9985 0
Australian Institute for Suicide Research and Prevention (AISRAP)
Griffith University
Mt Gravatt Campus
Nathan QLD 4111
Country 9985 0
Australia
Phone 9985 0
+61 7 37353380
Fax 9985 0
Email 9985 0
m.wyder@griffith.edu.au
Contact person for scientific queries
Name 913 0
Professor Diego De Leo
Address 913 0
Australian Institute for Suicide Research and Prevention (AISRAP)
Griffith University
Mt Gravatt Campus
Nathan QLD 4111
Country 913 0
Australia
Phone 913 0
+61 7 37353377
Fax 913 0
Email 913 0
d.deleo@griffith.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.