Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000084381
Ethics application status
Approved
Date submitted
12/02/2008
Date registered
14/02/2008
Date last updated
14/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dementia Care Mapping in residential aged care
Scientific title
Measuring the efficacy of Dementia Care Mapping in residential aged care: a randomised-controlled study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 2835 0
Condition category
Condition code
Neurological 2967 2967 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Detailed observations of person dementia to identify factors which promote well-being and ill-being. Interventions using Dementia Care Mapping (DCM) and Person Centred Care (PCC) models of care.
(1) DCM was conducted for all participating residents in the 5 DCM treatment units by CI A & CI D and two DCM trained staff from each of these 5 units "Mapping" occured continuously in 5 minute observation periods over eight hours during the waking day for three days per resident, in accordance with the specified rules outlined in the 7th edition of the DCM manual. The "mappers" fed back these findings to participating staff within 24 hours, to ensure they consider the identified relationship between care practices, staff-resident interactions and the residents' expressions of well-being and ill-being. Staff were assited by the "mappers" to develop residents' care plans which focus on person-centred care and resident well-being & this was implemented over 3 months.
(2) PCC education and training using Kitwood's PCC principles was provided to all participating staff in th efive PCC care units for six hours over two weeks by two PCC-trained staff from each of teh PCC units, under the supervision of CI E. PCC unit staff were assisted to develop residents' care plans which focus on person centred care and resident well-being by PCC-trained staff & to implement PCC over 3 months
Intervention code [1] 2556 0
Other interventions
Comparator / control treatment
Usual Care (UC) - standard care - is non-person centred care that is task focused & concerned mostly with physical care needs.
Control group
Active

Outcomes
Primary outcome [1] 3837 0
Well being in the person with dementia. This was measured using the following instruments:
(1) QUALID - Quality of Life in Late Stage Dementia
(2) Dementia Care Mapping Score
Timepoint [1] 3837 0
Followup at 4 months
Secondary outcome [1] 6465 0
Reduction in behavioural & psychological symptoms of dementia. The following instruments were used as measures:
(1) Neuropsychiatric Inventory (NPI)
(2) Cohen-Mansfield Agitation Inventory (CMAI).
Timepoint [1] 6465 0
Followup at 4 months
Secondary outcome [2] 6473 0
Compare the Effect of Dementia Care Mapping (DCM) & Person Centred Care (PCC) on: the quality of care for aged care residents with dementia,
Timepoint [2] 6473 0
Followup at 4 months
Secondary outcome [3] 6474 0
Compare the Effect of DCM & PCC on dementia patients levels of well being and behavioural disturbance
Timepoint [3] 6474 0
Followup at 4 months
Secondary outcome [4] 6475 0
Compare the Effect of DCM & PCC on staff's use of psychotropic medication and physical restraint of dementia patients
Timepoint [4] 6475 0
Followup at 4 months
Secondary outcome [5] 6476 0
Compare the effect of DCM & PCC on the cost of care of dementia patients and hospitalisation rates
Timepoint [5] 6476 0
Followup at 4 months
Secondary outcome [6] 6477 0
Compare the Effect of DCM & PCC on care staff's levels of stress, job satisfaction & turnover rates.
Timepoint [6] 6477 0
Followup at 4 months

Eligibility
Key inclusion criteria
Diagnosed dementia
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Terminal illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consented participants allocated to treatments by site. Allocation was done via Computer-Assisted randomisations at site level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised to sites and to treatments.
Method was: Permuted block randomisation at site level.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3081 0
Government body
Name [1] 3081 0
National Health & Medical Research Council
Country [1] 3081 0
Australia
Primary sponsor type
University
Name
University of Technology SYdney
Address
P.O. Box 222,
Eton Road,
Lindfield. NSW 2070
Country
Australia
Secondary sponsor category [1] 2775 0
Government body
Name [1] 2775 0
Australian Health Ministers - States & Territories
Address [1] 2775 0
Canberra. ACT
Country [1] 2775 0
Australia
Other collaborator category [1] 203 0
Other
Name [1] 203 0
Residential Dementia Care Units
Address [1] 203 0
Various throughout Sydney, NSW
Country [1] 203 0
Australia
Other collaborator category [2] 204 0
Other
Name [2] 204 0
Residential Dementia Care Units
Address [2] 204 0
Various throughout SYdney, NSW
Country [2] 204 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5030 0
UTS Human Research Ethics Committee
Ethics committee address [1] 5030 0
Ethics committee country [1] 5030 0
Australia
Date submitted for ethics approval [1] 5030 0
Approval date [1] 5030 0
19/02/2004
Ethics approval number [1] 5030 0
UTS HREC 03/1

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

Contacts
Principal investigator
Name 28368 0
Address 28368 0
Country 28368 0
Phone 28368 0
Fax 28368 0
Email 28368 0
Contact person for public queries
Name 11525 0
Professor Lynn Chenoweth
Address 11525 0
Health & Ageing Research Unit
War Memorial Hospital
125 Birrell Street,
Waverley. NSW 2024
Country 11525 0
Australia
Phone 11525 0
(02) 9369 0288
Fax 11525 0
Email 11525 0
[email protected]
Contact person for scientific queries
Name 2453 0
Professor Lynn Chenoweth
Address 2453 0
Health & Ageing Research Unit
War Memorial Hospital
125 Birrell Street,
Waverley. NSW 2024
Country 2453 0
Australia
Phone 2453 0
(02) 9369 0288
Fax 2453 0
Email 2453 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.