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Trial registered on ANZCTR


Registration number
ACTRN12610000775011
Ethics application status
Approved
Date submitted
8/09/2010
Date registered
16/09/2010
Date last updated
27/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of routine screening and feedback on post-stroke depression
Scientific title
In stroke patients with symptoms of depression, will automated feedback to clinicians from computerised depression screening, compared to no feedback, increase rates of identification and referral, and decrease depression at three month follow-up.
Secondary ID [1] 252580 0
n/a
Universal Trial Number (UTN)
U1111-1116-7365
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 258069 0
Stroke 258070 0
Condition category
Condition code
Mental Health 258232 258232 0 0
Depression
Stroke 258233 258233 0 0
Ischaemic
Stroke 258234 258234 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All potentially eligible patients undergo computerised depression screening once. Computerised screening involves administration of an individualised depression screen on a portable touchscreen computer, taking approximately 2-5 minutes, completed individually and in their own time in the presence of a research assistant.

Computerised screening begins with the Patient Health Questionnaire (PHQ) 2 item version. If scores on the PHQ2>0, the person is asked the remaining 7 items of the PHQ9. If total PHQ9 score >4, the person is given a problem list adapted from the Distress Thermometer problem list, and is considered eligible for the randomised controlled trial (RCT; unless suicidal or severe symptoms are expressed - in this case their clinician is always informed about their symptoms).
All patients screened are provided with 1 page written feedback regarding the severity of depression symptoms, with contact details regarding relevant stroke and depression services.

If eligible for the RCT and allocated to the intervention condition, a written feedback sheet detailing severity of depression, endorsed items on the problem list, and follow up care options is automatically produced and given to the patient's treating clinician immediately following screening.
Intervention code [1] 257099 0
Treatment: Other
Intervention code [2] 257217 0
Early detection / Screening
Comparator / control treatment
Computerised screening of depression and feedback to patient alone (1 page written feedback regarding the severity of depression symptoms, with contact details regarding relevant stroke and depression services). No written or verbal feedback is provided to the patient's treating clinician regarding results of the depression screening.
Control group
Active

Outcomes
Primary outcome [1] 259087 0
Depression identification, referral for mental health treatment or initiation of treatment (via file audit)
Timepoint [1] 259087 0
File audit of medical notes of the treating stroke/rehabilitation team between the depression screening appointment and 3 months post-screening follow-up.
Primary outcome [2] 259103 0
Depression severity as measured by the Patient Health Questionnaire 9 (PHQ9)
Timepoint [2] 259103 0
Baseline and 3 month follow-up
Secondary outcome [1] 265378 0
Diagnosis of Major Depressive Episode accoding to the Diagnositic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), using the Structured Clinical Interview for DSM-IV (SCID).
Timepoint [1] 265378 0
3 month follow-up

Eligibility
Key inclusion criteria
1. Confirmed stroke (ischaemic, haemorraghic, other)
2. Current symptoms of depression (Patient Health Questionnaire 9 score of 5 or above)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe/suicidal symptoms (PHQ9 score of 20 or above, or a score of 1 or above on PHQ9 item 9, thoughts of self harm)
2. Unable to read English
3. Lacks capactity to provide informed consent (e.g. moderate-severe dementia or significant cognitive deficits)
4. Refusal
5. Unavailable for 3 month phone follow-up

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)
All consecutive potentially eligible patients attending the stroke and rehabilitation clinics will be invited to participate in computerised depression screening.
Those with depression symptoms (not severe/suicidal) will be included in the intervention study and block randomised to the treatment or control condition. For patients in the treatment condition, the research assistant will provide the doctor feedback form to the clinicians. Allocation will not be concealed from the research assistant.
The Project Officer conducting the file audit and follow-up assessments will be blind to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation procedure will be used over a 6 month period. Each month all patients seen will be allocated to either treatment or control conditions. Randomisation order will be computer generated and kept off site. The research assistant will be informed of the randomisation allocation at the start of each month.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257549 0
Charities/Societies/Foundations
Name [1] 257549 0
National Stroke Foundation
Address [1] 257549 0
Level 7, 461 Bourke Street
Melbourne VIC 3000
Australia
Country [1] 257549 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 256781 0
Individual
Name [1] 256781 0
Dr Alyna Turner
Address [1] 256781 0
Heart Research Centre
Box 2137 Post Office
The Royal Melbourne Hospital
Victoria 3050
Country [1] 256781 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259574 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 259574 0
Locked Bag No 1
New Lambton, NSW, 2305
Ethics committee country [1] 259574 0
Australia
Date submitted for ethics approval [1] 259574 0
30/04/2010
Approval date [1] 259574 0
22/06/2010
Ethics approval number [1] 259574 0
10/05/19/5.06

Summary
Brief summary
The project will examine whether providing clinicians with feedback regarding depression symptoms, generated automatically following computerised depression screening, will result in higher rates of identification of depression, and treatment initation, and decrease rates of depression at 3 months post-screening.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31578 0
Address 31578 0
Country 31578 0
Phone 31578 0
Fax 31578 0
Email 31578 0
Contact person for public queries
Name 14825 0
Dr Alyna Turner
Address 14825 0
Heart Research Centre
Box 2137 Post Office
The Royal Melbourne Hospital
Victoria 3050
Country 14825 0
Australia
Phone 14825 0
+61 3 9326 8544
Fax 14825 0
+61 3 93265066
Email 14825 0
Alyna.turner@heartresearchcentre.org
Contact person for scientific queries
Name 5753 0
Dr Alyna Turner
Address 5753 0
Heart Research Centre
Box 2137 Post Office
The Royal Melbourne Hospital
Victoria 3050
Country 5753 0
Australia
Phone 5753 0
+61 3 9326 8544
Fax 5753 0
+61 3 93265066
Email 5753 0
Alyna.turner@heartresearchcentre.org

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