Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000564257
Ethics application status
Approved
Date submitted
9/07/2009
Date registered
9/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Personalised, one-to-one interaction using Montessori-type activities as a treatment of challenging behaviours in people with dementia: a pilot controlled trial.
Scientific title
Personalised, one-to-one interaction using Montessori-type activities as a treatment of challenging behaviours in people with dementia: a pilot controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe dementia 237153 0
Condition category
Condition code
Mental Health 237479 237479 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A researcher performs one to one, personalised activities (Montessori activities) with the resident for 30 min. for 2 weeks on two occasions during each week. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence and interests of the person involved.
Concerning the cross-over design: we will start the other condition in the week after we finish the first.
Intervention code [1] 236867 0
Behaviour
Comparator / control treatment
Talking with or reading to the resident for 30 min. for 2 weeks on two occasions during each week.
Control group
Active

Outcomes
Primary outcome [1] 238284 0
One or two physically agitated behaviours that occur as a consequence of the dementia.
Timepoint [1] 238284 0
Observations 30 min. before, 30 min. during and 30 min. after doing the Montessori or control activities. For each minute the presence of absence of the chosen target behaviours is noted.
Secondary outcome [1] 244657 0
Engagement.
Timepoint [1] 244657 0
Observations 30 min. before, 30 min. during and 30 min. after doing the Montessori or control activities. For each minute the predominant form of engagement is noted.
Secondary outcome [2] 244658 0
Affect.
Timepoint [2] 244658 0
Observations 30 min. before, 30 min. during and 30 min. after doing the Montessori or control activities. For each minute the predominant type of affect is noted.
Secondary outcome [3] 244659 0
Physical and verbal agitation using Cohen Mansfield Agitation Inventory (CMAI).
Timepoint [3] 244659 0
At the end of the two-week period in which Montessori activities are done and at the end of the two-week period in which control activities are done.

Eligibility
Key inclusion criteria
In nursing home facility for at least 3 months.
History of moderate to severe dementia.
Stable medical, psychological and drugs regime.
Agitated (physical) behaviours occur several times an hour on a daily basis and are not associated with activities of daily living (ADL-activities).
The behaviours are not due to pain, physical illness, depression or psychosis.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of a acutely life threatening illness.
The agitated behaviours are dangerous to researchers.

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)
We will use an efficient, economical design with random allocation to treatment or control conditions followed by cross-over. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are exposed to Montessori and control conditions in random order (A-B or B-A). A senior researcher will generate random numbers using Microsoft Excel Random Generator software. When participants fall due for randomisation, she will allocate to sequence A-B if the next number is even and B-A if odd.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1874 0
3192
Recruitment postcode(s) [2] 1875 0
3199
Recruitment postcode(s) [3] 1876 0
3177
Recruitment postcode(s) [4] 1877 0
3162

Funding & Sponsors
Funding source category [1] 237256 0
Other Collaborative groups
Name [1] 237256 0
Dementia Collaborative Research Centre (DCRC)
Country [1] 237256 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham
3192 VIC
Country
Australia
Secondary sponsor category [1] 236742 0
Hospital
Name [1] 236742 0
Southern Health
Address [1] 236742 0
246 Clayton Road
Clayton
3168 VIC
Country [1] 236742 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239357 0
Southern Health
Ethics committee address [1] 239357 0
Ethics committee country [1] 239357 0
Australia
Date submitted for ethics approval [1] 239357 0
Approval date [1] 239357 0
05/05/2008
Ethics approval number [1] 239357 0
08012A
Ethics committee name [2] 239358 0
Peninsula Health
Ethics committee address [2] 239358 0
Ethics committee country [2] 239358 0
Australia
Date submitted for ethics approval [2] 239358 0
Approval date [2] 239358 0
10/06/2009
Ethics approval number [2] 239358 0
2009-24
Ethics committee name [3] 239359 0
Alfred Health
Ethics committee address [3] 239359 0
Ethics committee country [3] 239359 0
Australia
Date submitted for ethics approval [3] 239359 0
11/07/2009
Approval date [3] 239359 0
Ethics approval number [3] 239359 0

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

Contacts
Principal investigator
Name 29842 0
Address 29842 0
Country 29842 0
Phone 29842 0
Fax 29842 0
Email 29842 0
Contact person for public queries
Name 13089 0
Eva van der Ploeg
Address 13089 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham
3192 VIC
Country 13089 0
Australia
Phone 13089 0
+61 3 9256 1707
Fax 13089 0
Email 13089 0
[email protected]
Contact person for scientific queries
Name 4017 0
Eva van der Ploeg
Address 4017 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham
3192 VIC
Country 4017 0
Australia
Phone 4017 0
+61 3 9256 1707
Fax 4017 0
Email 4017 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.