Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000248864
Ethics application status
Approved
Date submitted
8/01/2021
Date registered
8/03/2021
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Mood and other factors related to attitudes toward euthanasia in older people with depression
Scientific title
The effects of mood and psychosocial factors in the endorsement of euthanasia by older people without a terminal physical illness
Secondary ID [1] 303127 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 320231 0
Euthanasia 320232 0
Condition category
Condition code
Mental Health 318167 318167 0 0
Depression
Mental Health 318513 318513 0 0
Suicide

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be enrolled from Older Person's Mental Health Service (OPMHS). Regardless of whetehr the participant chooses to enrol they will be treated by the OPMHS. They will complete questionnaires regarding demographics, personality (Ten Item Personality Inventory), mood (K10), euthanasia attitudes (Attitudes Towards Euthanasia Scale), attitudes towards suicide (Attitudes Towards Suicide Scale), feelings of burdensomeness (Interpersonal Needs Questionnaire-6 item burdensome subset) and quality of life (Quality Of Life Scale). This is projected to take a total of 60 minutes. They will then be treated by their service for 6 months, and the same questionnaires will then be repeated. Scores will be compared for significance. The patients will complete these questionnaires on a computer. Whether this is an emailed link to their personal computer with internet access or a computer set up in the service is their preference. There will be no assistance to complete the questionnaires from researchers in either case.

This is observational in nature as the research is not changing intervention of depression, rather taking a naturalistic view of the typical treatment process of depression.

Typically treatment provided for depression would be specific to the patient. This may include social support, antidepressant prescription, psychological therapies, Exercise Programs and family support.
Intervention code [1] 319425 0
Diagnosis / Prognosis
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326153 0
Attitudes towards euthanasia via attitudes towards euthanasia scale
Timepoint [1] 326153 0
Baseline and 6 months
Secondary outcome [1] 390262 0
quality of life via Quality of Life Scale
Timepoint [1] 390262 0
Baseline and 6 months
Secondary outcome [2] 390263 0
attitudes towards suicide via attitudes towards suicide scale
Timepoint [2] 390263 0
Baseline and 6 months
Secondary outcome [3] 390264 0
perceived burdensomeness via interpersonal needs questionnaire-6 item subset on burdensomeness
Timepoint [3] 390264 0
Baseline and 6 months
Secondary outcome [4] 390265 0
Personality style via Ten Item Personality Inventory
Timepoint [4] 390265 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Age 65+
Absence of cognitive and functional impairment (MMSE greater than or equal to 24)
Diagnosis of depression by older person’s mental health service at Royal North Shore
No active malignancy, neurological disease or other disease that may be considered terminal
Absence of psychosis
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychosis in context of primary psychotic illness or depression
Active drug or alcohol dependence

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Power calculations showed 31 participants were needed to enrol. Using power calculation of Beta 0.9 and alpha 0.05 and mean on ATE scale of 20.78 and a standard deviation of 2.94 and expected result of 22.5 the sample size should be 31.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/03/2021
Actual
Date of last participant enrolment
Anticipated
16/09/2021
Actual
Date of last data collection
Anticipated
13/03/2022
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18376 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 18377 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 18378 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 32456 0
2031 - Randwick
Recruitment postcode(s) [2] 32457 0
2065 - St Leonards
Recruitment postcode(s) [3] 32458 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 307533 0
Self funded/Unfunded
Name [1] 307533 0
Adjunct Associate Professor Chanaka Wijeratne
Country [1] 307533 0
Australia
Primary sponsor type
Individual
Name
Adjunct Associate Professor Chanaka Wijeratne
Address
Older Person's Mental Health Service, 2c Herbert St, St Leonards 2065 NSW
Country
Australia
Secondary sponsor category [1] 308211 0
Individual
Name [1] 308211 0
Dr James Baee
Address [1] 308211 0
Older Person's Mental Health Service, 2c Herbert St, St Leonards 2065 NSW
Country [1] 308211 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307598 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307598 0
Ethics committee country [1] 307598 0
Australia
Date submitted for ethics approval [1] 307598 0
22/12/2020
Approval date [1] 307598 0
23/12/2020
Ethics approval number [1] 307598 0

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

Contacts
Principal investigator
Name 107814 0
A/Prof Chanaka Wijeratne
Address 107814 0
Older Perons's Mental Health Service, 2c Herbert St, St Leonards 2065 NSW
Country 107814 0
Australia
Phone 107814 0
+61 431437722
Fax 107814 0
Email 107814 0
[email protected]
Contact person for public queries
Name 107815 0
James Baee
Address 107815 0
Older Perons's Mental Health Service, 2c Herbert St, St Leonards 2065 NSW
Country 107815 0
Australia
Phone 107815 0
+61 2 9926 9333
Fax 107815 0
Email 107815 0
[email protected]
Contact person for scientific queries
Name 107816 0
Chanaka Wijeratne
Address 107816 0
Older Perons's Mental Health Service, 2c Herbert St, St Leonards 2065 NSW
Country 107816 0
Australia
Phone 107816 0
+61 2 9926 9333
Fax 107816 0
Email 107816 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will only be collected for this research and will not be made available for any further research


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10201Informed consent form    381189-(Uploaded-08-02-2021-16-32-23)-Study-related document.doc



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.