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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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
Mental Health 286468 286468 0 0
Mental Health 286469 286469 0 0
Other mental health disorders

Study type
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

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
Timepoint [1] 296989 0

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
Both males and females
Can healthy volunteers participate?
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
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285067 0
Self funded/Unfunded
Name [1] 285067 0
Eswaran Waran
Address [1] 285067 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South,
SA 5011
Country [1] 285067 0
Primary sponsor type
Dr Eswaran Waran
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South,
SA 5011
Secondary sponsor category [1] 283929 0
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
Approval date [1] 287090 0
Ethics approval number [1] 287090 0

Brief summary
This study seeks to determine if the use of a simple questionnaire can enhance the detection of carer distress in the Palliative care carer population.
Trial website
Trial related presentations / publications
Public notes

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
Phone 17285 0
+61 08 82226000
Fax 17285 0
+61 08 82226055
Email 17285 0
Contact person for scientific queries
Name 8213 0
Dr Eswaran Waran
Address 8213 0
28 Woodville Road
Woodville South, SA, 5011
Country 8213 0
Phone 8213 0
+61 08 82226000
Fax 8213 0
+61 08 82226055
Email 8213 0

No information has been provided regarding IPD availability
Summary results
No Results