Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000183088
Ethics application status
Approved
Date submitted
23/02/2010
Date registered
1/03/2010
Date last updated
13/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Intervention for Depression Among Palliative Care Patients and their Families: Training Program for Care Staff
Scientific title
Among palliative care patients and their families, is a training intervention delivered to palliative care staff to detect and intervene when palliative care patients experience depression, compared with no training intervention, effective in improving their health and quality of life as well as improve palliative care staffs detection of depression and knowledge, positive attitudes, self-efficacy and care practices towards depressed palliative care patients?
Secondary ID [1] 1448 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 256804 0
Condition category
Condition code
Mental Health 256955 256955 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be investigating the efficacy of a four-session training program for palliative care staff that aims to improve the detection, monitoring and management of depression in people receiving palliative care. The four 90-min sessions, delivered over approximately a month to groups of 8-10 staff members, will aim to train staff to better understand depression, understand masked depression, monitor and screen for depression and improve their communication skills and support for depressed patients and their family members.
Intervention code [1] 256010 0
Other interventions
Comparator / control treatment
Wait-list control group of palliative care staff receiving no training. Following a three-month followup testing of the experimental group on the outcome measures this wait-list control group will then receive the training intervention.
Control group
Active

Outcomes
Primary outcome [1] 257828 0
Improvement on Staff Knowledge of Depression Scale
Timepoint [1] 257828 0
pre- and post- training and three month follow-up
Primary outcome [2] 257829 0
Staff improvement on Attitudes to Depression Questionnaire
Timepoint [2] 257829 0
pre- and post- training and three month follow-up
Primary outcome [3] 257830 0
Staff improvement on Self-Efficacy in Working with Depression Scale
Timepoint [3] 257830 0
pre- and post- training and three month follow-up
Primary outcome [4] 257831 0
Staff improvement on Barriers to Care of Depression Scale
Timepoint [4] 257831 0
pre- and post- training and three month followup
Primary outcome [5] 257832 0
Staff improvement on Scale of Performance as assessed by staff managers
Timepoint [5] 257832 0
pre- and post-training and three month followup
Primary outcome [6] 257833 0
Improvement in knowledge and specific skills of staff in working with palliative care patients using semi-structured interviews with managers and families.
Timepoint [6] 257833 0
pre- and post-training
Primary outcome [7] 257834 0
Improvement in staff's detection of depression among people under their care by indicating which of a list of participating care recipients they perceive to be to be currently depressed. This will be evaluated by a comparison with diagnoses made by a clinical psychologist using a structured clinical interview (SCID) on a randomly selected sample of 50% of participating patients to determine the presence or absence of Major Depressive Disorder or Minor Depressive Disorder.
Timepoint [7] 257834 0
pre- and post- training
Primary outcome [8] 257835 0
Depression detection and referrals will improve in primary and specialist health services. This will me monitored by referral rates given from primary care physicians and participating staff who will be asked to keep records of referrals which will be validated by examination of files
Timepoint [8] 257835 0
pre- and post-training and three month followup
Secondary outcome [1] 263249 0
Family members will be interviewed to determine the change in mental health of palliative care patients as well as changes to patients and their quality of life as a result of changes in staff practices
Timepoint [1] 263249 0
pre- and post- training

Eligibility
Key inclusion criteria
Palliative care facility staff (direct carers/care assistants and senior staff including Division 1 and 2 nurses, and other allied health professionals) and family members of patients of palliative care facilities
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
non-English speaking staff

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2010
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)
Recruitment postcode(s) [1] 2604 0
3152
Recruitment postcode(s) [2] 2605 0
3280

Funding & Sponsors
Funding source category [1] 256513 0
Government body
Name [1] 256513 0
Australian Government Department of Health and Ageing
Country [1] 256513 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood Victoria 3125
Australia
Country
Australia
Secondary sponsor category [1] 255821 0
Hospital
Name [1] 255821 0
Eastern Health
Address [1] 255821 0
Peter James Centre
Mahoneys Road, Burwood East VIC 3153
Country [1] 255821 0
Australia
Secondary sponsor category [2] 255822 0
Hospital
Name [2] 255822 0
South West Healthcare
Address [2] 255822 0
Warrnambool Hospital
Ryot St, Warrnambool VIC 3280
Country [2] 255822 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258578 0
Deakin University Research Ethics Committee
Ethics committee address [1] 258578 0
Ethics committee country [1] 258578 0
Australia
Date submitted for ethics approval [1] 258578 0
Approval date [1] 258578 0
Ethics approval number [1] 258578 0

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

Contacts
Principal investigator
Name 30833 0
Address 30833 0
Country 30833 0
Phone 30833 0
Fax 30833 0
Email 30833 0
Contact person for public queries
Name 14080 0
Martia McCabe
Address 14080 0
221 Burwood Highway, Burwood, Victoria, Australia, 3125
Country 14080 0
Australia
Phone 14080 0
+61 3 92446856
Fax 14080 0
+61 3 92446858
Email 14080 0
[email protected]
Contact person for scientific queries
Name 5008 0
Marita McCabe
Address 5008 0
221 Burwood Highway, Burwood, Victoria, Australia, 3125
Country 5008 0
Australia
Phone 5008 0
+61 3 92446856
Fax 5008 0
+61 3 92446858
Email 5008 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.