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Trial registered on ANZCTR


Registration number
ACTRN12610000324011
Ethics application status
Approved
Date submitted
6/04/2010
Date registered
21/04/2010
Date last updated
21/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of the multi-component tailored intervention in treatment of behavioral and psychological symptoms in dementia (BPSD).
Scientific title
The multi-component tailored intervention in treatment of demented residents with behavioral and psychological symptoms in dementia (BPSD) to alleviate symptoms. Randomized controlled trial.
Secondary ID [1] 251625 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioral and psychological symptoms in dementia (BPSD) 257097 0
Condition category
Condition code
Neurological 257252 257252 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention duration: 14 months. The staff in the intervention wards is supported by the mentor nurse and consulting geriatrician to find the underlying multiple interacting causes of each resident’s behaviour, and to provide individually tailored, comprehensive and multi-component intervention. The intervention is tailored on basis on care wards. Mentor nurse and geriatrician are available on daily basis but actual freqencies and times are based on needs of wards. Mentoring takes place on a one to one basis and in group meetings. Tailoring is the very important principle of intervention
Intervention code [1] 256264 0
Other interventions
Comparator / control treatment
Two training sessions ( two afternoons, 4 hr each) with a neurology and a gerontologist nurse (not with the mentor) about BPSD are arranged to the staff in control wards. There were lectures regarding to diseases causing dementia and medical and nursing care of dementia
Control group
Active

Outcomes
Primary outcome [1] 258159 0
1. Alleviation of BPSD among the residents with BPSD. The study nurse collects data with different methods at baseline, 6 months and 14 months by interviewing each resident's primary nurse. Method for BPSD is Neuropsychiatric Interventory- nursing home version (NPI-NH)
Timepoint [1] 258159 0
14 months (the end of the study period)
Secondary outcome [1] 263793 0
Prevalence and severity of BPSD in the study wards. Data of BPSD with NPI-NH are collected by the study at baseline and 14 months from all the residents in each ward.
Timepoint [1] 263793 0
14 months (the end of the study period)
Secondary outcome [2] 263794 0
Use of medication
The study nurse collects the lists of medication of each reidents at baseline, 6 and 14 months.
Timepoint [2] 263794 0
14 months (the end of the study period)
Secondary outcome [3] 263795 0
Well-being of residents with dementia is assessed by two proxy methods. Quality of Life in Late Stage Dementia (QUALID) is collected by the study nurse at baseline, 6 and 14 months. Furthermore, Quality of Life in Dementia Observation tool (ELO-D) is used by two trained ELO-D users during eight hours (10 am-6 pm) in one day, at baseline and 14 months.
Timepoint [3] 263795 0
14 months (the end of the study period)

Eligibility
Key inclusion criteria
Resident with dementia (with specific etiological diagnosis) and with BPSD
Minimum age
50 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Resident is entered to terminal care or is planned to be transferred to another care unit or home

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)
All long term care wards in the City of Espoo are participated in the study. Allocation was done by central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation: blocked randomization
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2570 0
Finland
State/province [1] 2570 0

Funding & Sponsors
Funding source category [1] 256765 0
Charities/Societies/Foundations
Name [1] 256765 0
The Slot Machine Association of finland
Address [1] 256765 0
Turuntie 42, 02650 Espoo, Finland
Country [1] 256765 0
Finland
Primary sponsor type
Charities/Societies/Foundations
Name
The Central Union for the Welfare of the Aged
Address
Malmin kauppatie 26, 00700 Helsinki, Finland
Country
Finland
Secondary sponsor category [1] 256045 0
Government body
Name [1] 256045 0
The National Institute for Health and Welfare (THL)
Address [1] 256045 0
P.O. Box 30, FI-00271 Helsinki, Finland
Country [1] 256045 0
Finland
Secondary sponsor category [2] 256046 0
University
Name [2] 256046 0
University of Eastern Finland
Address [2] 256046 0
P.O. Box 1627
FI-70211 Kuopio, Finland
Country [2] 256046 0
Finland
Other collaborator category [1] 1188 0
University
Name [1] 1188 0
Sibelius Academy
Address [1] 1188 0
P.O.Box 86
FIN-00251 Helsinki, Finland
Country [1] 1188 0
Finland
Other collaborator category [2] 1189 0
Charities/Societies/Foundations
Name [2] 1189 0
The Age Institute
Address [2] 1189 0
Kalevankatu 12 A, 00100 Helsinki, Finland
Country [2] 1189 0
Finland
Other collaborator category [3] 1190 0
Charities/Societies/Foundations
Name [3] 1190 0
The Society of Memory Disorders expertise in Finland
Address [3] 1190 0
Fredriksberginkatu 2
00240 Helsinki, Finland
Country [3] 1190 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258790 0
The Ethic Committee of Hospital District of Helsinki and Uusimaa
Ethics committee address [1] 258790 0
Biomedicum Helsinki 2 C, PL 705, 00029 HUS, Finland
Ethics committee country [1] 258790 0
Finland
Date submitted for ethics approval [1] 258790 0
12/04/2008
Approval date [1] 258790 0
06/06/2008
Ethics approval number [1] 258790 0
153/13/03/00/08

Summary
Brief summary
The primary purpose of the study is to determine if a multicomponent support program coordinated by a mentor nurse is efficient in alleviating BPSD. The hypothesis is (1) that there are various kinds of triggering factors for BPSD and treatment solututions may be found by supporting personnel systematically and multiprofessionally to understand those triggering factors and (2) that care provided in these grounds alleviates BPSD
Trial website
www.mielenmuutos.fi -> Dementia Study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31021 0
Address 31021 0
Country 31021 0
Phone 31021 0
Fax 31021 0
Email 31021 0
Contact person for public queries
Name 14268 0
Ulla Eloniemi-Sulkava
Address 14268 0
The Central Union for the Welfare of the Aged
Malmin kauppatie 26
00700 Helsinki, Finland
Country 14268 0
Finland
Phone 14268 0
+358 50 5180907
Fax 14268 0
+350 9 350 86010
Email 14268 0
ulla.eloniemi-sulkava@vtkl.fi
Contact person for scientific queries
Name 5196 0
Ulla Eloniemi-Sulkava
Address 5196 0
The Central Union for the Welfare of the Aged
Malmin kauppatie 26
00700 Helsinki, Finland
Country 5196 0
Finland
Phone 5196 0
+358 50 5180907
Fax 5196 0
+350 9 350 86010
Email 5196 0
ulla.eloniemi-sulkava@vtkl.fi

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary