Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001037099
Ethics application status
Approved
Date submitted
7/11/2010
Date registered
24/11/2010
Date last updated
24/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Specialist mental health consultation for depression in Australian aged care residents with dementia.
Scientific title
In aged care residents with dementia, is specialist mental health consultation more effective than care as usual in the management of major depression?
Secondary ID [1] 253039 0
Nil
Universal Trial Number (UTN)
U1111-1117-7992
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 258598 0
Condition category
Condition code
Mental Health 258742 258742 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the intervention condition, a psychiatrist and clinical psychologist provided individually tailored medical and psychosocial recommendations to facility care staff and General Practitioners. The intervention was thus a form of consultation and training designed to improve care staff and GP management of depression. The frequency with which the psychiatrist and psychologist had contact with those providing direct care varied on a case by case basis, throughout the course of the study. The duration of the intervention was 15 weeks.
Intervention code [1] 257565 0
Other interventions
Comparator / control treatment
The control treatment was standard care, which typically involved GP management of depression (including the use of various antidepressants) and involvement in an activities program at the facility. Activity programs offered at each facility varied markedly, as did the level of involvement of individual participants. Standard care paralelled the intervention for approximately 15 weeks.
Control group
Active

Outcomes
Primary outcome [1] 259603 0
Cornell Scale for Depression in Dementia (CSDD)
Timepoint [1] 259603 0
Approximately 15-weeks after intervention commencement
Primary outcome [2] 259604 0
DSM-IV Depression Diagnosis were also made, facilitated by checklists of DSM-IV criteria. Note that standard diagnostic tests could not be used, because our participants all had considerable cognitive impairment. The assessing clinician reviewed all potential cases with a senior team member in order to confirm the diagnosis.
Timepoint [2] 259604 0
Approximately 15-weeks after intervention commencement
Secondary outcome [1] 266244 0
Rating Anxiety in Dementia (RAID) Scale
Timepoint [1] 266244 0
Approximately 15-weeks after intervention commencement
Secondary outcome [2] 266245 0
Behavioral and Psychological Symptoms of Dementia, as measured by the BEHAVE-AD.
Timepoint [2] 266245 0
Approximately 15-weeks after intervention commencement

Eligibility
Key inclusion criteria
Permanent resident of aged care facility; </= 23 on the MMSE and a PAS Cognitive Decline Informant History of greater than or equal to 4 or their facility record referred to presence of cognitive impairment; diagnosis of DSM-IV Major Depression.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No history of English language proficiency; the resident did not have a family member or friend who could provide information about the resident's emotional well-being.

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)
Study was a clustered randomized controlled trial where individual facilities were randomized. Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Facilities were randomized by coin-toss.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Study was a clustered randomized controlled trial where individual facilities were randomized.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3412 0
3192
Recruitment postcode(s) [2] 3413 0
3162
Recruitment postcode(s) [3] 3414 0
3196
Recruitment postcode(s) [4] 3415 0
3186
Recruitment postcode(s) [5] 3416 0
3191
Recruitment postcode(s) [6] 3417 0
3194
Recruitment postcode(s) [7] 3418 0
3163
Recruitment postcode(s) [8] 3419 0
3181
Recruitment postcode(s) [9] 3420 0
3168
Recruitment postcode(s) [10] 3421 0
3206
Recruitment postcode(s) [11] 3422 0
3174
Recruitment postcode(s) [12] 3423 0
3187
Recruitment postcode(s) [13] 3424 0
3150

Funding & Sponsors
Funding source category [1] 258016 0
Charities/Societies/Foundations
Name [1] 258016 0
beyondblue: the national depression initiative
Country [1] 258016 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 257210 0
None
Name [1] 257210 0
Address [1] 257210 0
Country [1] 257210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260009 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 260009 0
Ethics committee country [1] 260009 0
Australia
Date submitted for ethics approval [1] 260009 0
Approval date [1] 260009 0
12/04/2007
Ethics approval number [1] 260009 0
CF07/0146 - 2007/0032

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

Contacts
Principal investigator
Name 31882 0
Address 31882 0
Country 31882 0
Phone 31882 0
Fax 31882 0
Email 31882 0
Contact person for public queries
Name 15129 0
Professor Daniel O'Connor
Address 15129 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham
VICTORIA 3192
Country 15129 0
Australia
Phone 15129 0
+61 3 9265 1700
Fax 15129 0
+61 3 9265 1711
Email 15129 0
[email protected]
Contact person for scientific queries
Name 6057 0
Professor Daniel O'Connor
Address 6057 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham
VICTORIA 3192
Country 6057 0
Australia
Phone 6057 0
+61 3 9265 1700
Fax 6057 0
+61 3 9265 1711
Email 6057 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.