Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000647437
Ethics application status
Approved
Date submitted
17/12/2007
Date registered
20/12/2007
Date last updated
20/12/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, controlled evaluation of the ‘beyondblue depression training program for aged care staff’: Impact on the delivery of health care services for older people with depression
Scientific title
A randomised, controlled evaluation of the ‘beyondblue depression training program for aged care staff’: Impact on the delivery of health care services for older people with depression
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 2649 0
Condition category
Condition code
Mental Health 2764 2764 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a training programme for care staff in the precognition and detection of depression. Personal carers in residential facilities and direct carers in community services will participate in five 1.5 hour training sessions over 5 weeks that provide information on the nature and prevalence of depression amongst the elderly, symtoms and comorbidities. They will be taught to use a simple checklist of depression symtomatology, how to communicate with older depressed people, how to respond to depression, and how to facilitate referral of depressed people to appropriate services. Registered Nurses (residential) and Case managers (community) will particpate in these four sessions and two further 2 hours sessions focused on the use of standardised instruments to assess for depression, and liaison with General Practitioners.
Intervention code [1] 2384 0
Diagnosis / Prognosis
Intervention code [2] 2385 0
Early detection / Screening
Comparator / control treatment
No training
Control group
Active

Outcomes
Primary outcome [1] 3641 0
Improved self-efficacy in relation to caring for older people with depression as assessed by the Self-Efficacy in Working with Late-Life Depression Scale;
Timepoint [1] 3641 0
Assessed at pre- and post-intervention, and 6 months follow-up
Primary outcome [2] 3651 0
Improved detection rates of depression among their care recipients and a higher number of referrals to medical services
Timepoint [2] 3651 0
Assessed at pre- and post-intervention, and 6 months follow-up
Secondary outcome [1] 6115 0
Improved knowledge of late-life depression and more positive attitudes to the care of older people with depression, as measured by Knowledge of Late-Life Depression Scale and the Attitudes to Depression Questionnaire
Timepoint [1] 6115 0
Assessed at pre- and post-intervention, and 6 months follow-up
Secondary outcome [2] 6136 0
Improved care practices as assessed by Scale of Nursing Performance, and by directly comparing carers' assessments of the levels of depression among a sample of 10 care recipients from each residential service with assessments made by a Clinical Psychologist who will use the Structured Clinical Interview Schedule for Axis I Disorders
Timepoint [2] 6136 0
Six month follow up

Eligibility
Key inclusion criteria
Care staff and care managers in community based aged care services and low level care residential facilities speak English
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Care staff who do not speak English

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Four low-level care residential facilities and four community aged care services, drawn from Benetas and Uniting Aged Care aged care services, will take part in this study. Services will be randomly allocated to either (a) the training group, who receive the ‘beyondblue depression training program for aged care staff’ (two residential and two community services), or (b) the wait list control group (n = 80 staff; two residential and two community services). Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will take place by coin-tossing
Masking / blinding
Open (masking not 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
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 347 0
3125

Funding & Sponsors
Funding source category [1] 2904 0
Government body
Name [1] 2904 0
National Depression Initiative - Beyondblue
Country [1] 2904 0
Australia
Primary sponsor type
University
Name
Deakin Univesrity
Address
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 2622 0
Government body
Name [1] 2622 0
Eastern Health
Address [1] 2622 0
Locked Bag No. 1
Post Office
Forest Hill VIC 3131
Country [1] 2622 0
Australia
Other collaborator category [1] 110 0
Charities/Societies/Foundations
Name [1] 110 0
Benetas
Address [1] 110 0
789 Toorak Road
Hawthorn East VIC 3123
Country [1] 110 0
Australia
Other collaborator category [2] 111 0
Charities/Societies/Foundations
Name [2] 111 0
Uniting Aged Care Victoria and Tasmania
Address [2] 111 0
Level 6
130 Little Collins Street
Melbourne VIC 3000
Country [2] 111 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4835 0
Deakin University Human Research Ethics Committe
Ethics committee address [1] 4835 0
Ethics committee country [1] 4835 0
Australia
Date submitted for ethics approval [1] 4835 0
Approval date [1] 4835 0
01/09/2006
Ethics approval number [1] 4835 0
EC 215-2006

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

Contacts
Principal investigator
Name 28247 0
Address 28247 0
Country 28247 0
Phone 28247 0
Fax 28247 0
Email 28247 0
Contact person for public queries
Name 11404 0
Associate Professor David Mellor
Address 11404 0
School of Psychology
Deakin University
Burwood VIC 3125
Country 11404 0
Australia
Phone 11404 0
+61 3 92443742
Fax 11404 0
+61 3 92446858
Email 11404 0
[email protected]
Contact person for scientific queries
Name 2332 0
Professor Marita McCabe
Address 2332 0
School of Psychology
Deakin University
Burwood VIC 3125
Country 2332 0
Australia
Phone 2332 0
+61 3 92446856
Fax 2332 0
+61 3 92446858
Email 2332 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.