Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000409875
Ethics application status
Not yet submitted
Date submitted
10/04/2012
Date registered
12/04/2012
Date last updated
12/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of a formal tool ( Kessler 10 ) improve the detection of carer distress in the Palliative population.
Scientific title
In the carers of Palliative care patients, does the use of a formal tool ( Kessler 10 ) in comparison to community palliative care nurse clinical judgement improve detection of carer distress
Secondary ID [1] 280293 0
NIL
Universal Trial Number (UTN)
U1111-1129-8848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological distress 286249 0
Condition category
Condition code
Mental Health 286467 286467 0 0
Depression
Mental Health 286468 286468 0 0
Anxiety
Mental Health 286469 286469 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Kessler 10 ( K 10 ), is the intervention studied. This is a questionnaire to detect psychological distress. It is a validated and recognized screening tool for psychological distress. In this study it will be used to asses carer psychological distress. The K 10 takes approximately 5 minutes to complete. This will only have to be completed on one occasion in the trial.
Intervention code [1] 284646 0
Early detection / Screening
Comparator / control treatment
Community nurse assessment of psychlogical distress. This will be based on our current asessment of carer psychological distress, which is the community nurse clinical judgement. This will be undertaken at the same visit that the carer is provided their K 10 questionnaire. The carer as per ethics does not have to complete the K 10 immediately, but once completed are required to post the K 10 back to the investigator.
Control group
Active

Outcomes
Primary outcome [1] 286918 0
Level of psychological distress. Comparison between K 10 scores as generated by patient completion of questionaire and the community nurse assessment. K 10 scores are stratified into groups that include nil distress, mild mental distress, moderate mental distress and severe mental distress. The community nurse will assess the level of distress as being well, mild, moderate and severe, based on clinical judgement. For statistical analysis scores of 1,2,3 and 4 will be given to the categories of well, mild, moderate and severe distress respectively. As a result total scores can be arrived at for each assessment for mean comparison.
Timepoint [1] 286918 0
baseline single assessment for each group only
Secondary outcome [1] 296989 0
Nil
Timepoint [1] 296989 0
NA

Eligibility
Key inclusion criteria
Only subjects identifying themselves as principal carers will be asked to participate. The carers are carers of Palliative care patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Carers for whom there may be a communication issue, for example language barrier, will be excluded as consent would be an issue

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be exposed to both the intervention and the standard treatments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285067 0
Self funded/Unfunded
Name [1] 285067 0
Eswaran Waran
Country [1] 285067 0
Australia
Primary sponsor type
Individual
Name
Dr Eswaran Waran
Address
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South,
SA 5011
Country
Australia
Secondary sponsor category [1] 283929 0
None
Name [1] 283929 0
Address [1] 283929 0
Country [1] 283929 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287090 0
Ethics committee address [1] 287090 0
Ethics committee country [1] 287090 0
Date submitted for ethics approval [1] 287090 0
27/04/2012
Approval date [1] 287090 0
Ethics approval number [1] 287090 0

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

Contacts
Principal investigator
Name 34038 0
Address 34038 0
Country 34038 0
Phone 34038 0
Fax 34038 0
Email 34038 0
Contact person for public queries
Name 17285 0
Dr Eswaran Waran
Address 17285 0
28 Woodville Road
Woodville South, SA, 5011
Country 17285 0
Australia
Phone 17285 0
+61 08 82226000
Fax 17285 0
+61 08 82226055
Email 17285 0
[email protected]
Contact person for scientific queries
Name 8213 0
Dr Eswaran Waran
Address 8213 0
28 Woodville Road
Woodville South, SA, 5011
Country 8213 0
Australia
Phone 8213 0
+61 08 82226000
Fax 8213 0
+61 08 82226055
Email 8213 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.