Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000189426
Ethics application status
Approved
Date submitted
30/03/2007
Date registered
2/04/2007
Date last updated
12/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectivess of a support model for elderly families with dementia
Scientific title
Family Care as Collaboration: The Effectiveness of a Rehabilitation Model for Elderly Families with Dementia. A randomised controlled intervention study and qualitative process research
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia, family caregiving 1707 0
Condition category
Condition code
Neurological 1799 1799 0 0
Dementias
Physical Medicine / Rehabilitation 1800 1800 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Duration of study: 24 months
Intervention group:
Family care coordinator, geriatrician and individually tailored and need-based support activities (24 months). Families met the family care co-ordinator and the geriatrician at the beginning of the intervention and after that when needed (need-based and individually tailored consultations, in-home visits and follow-up calls)
Goal-orientated peer support group meetings for caregivers ( 5 meetings with 8-10 participants in two months' intervals during the first intervention year, each meeting for 5 hours, including peer support sessions of 2 hours and recreational elements.Spouses with dementia had their own rehabilitation groups at the same time.
Intervention code [1] 1679 0
Rehabilitation
Comparator / control treatment
Control group: active (standard care: usual services provided for patients/ clients in community care by the municipal social and health care system)
Control group
Active

Outcomes
Primary outcome [1] 2520 0
Time to long term institutional care (the period in community care) from enrolment of the couples in the study to long term institutional care of people with dementia
Timepoint [1] 2520 0
At the end of intervention
Secondary outcome [1] 4348 0
Well-being of spouse caregivers
Timepoint [1] 4348 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [2] 4349 0
Burden of spouse caregivers
Timepoint [2] 4349 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [3] 4350 0
Quality of life of spouse caregivers
Timepoint [3] 4350 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [4] 4351 0
Mortality of couples
Timepoint [4] 4351 0
At the end of intervention
Secondary outcome [5] 4352 0
Use of services and service expenditures
Timepoint [5] 4352 0
At the end of intervention

Eligibility
Key inclusion criteria
Family: A spouse caring his/ her partner with dementia, living in the City of Helsinki, FinlandPatient: the minimum score of 1 in Clinical Dementia Rating Scale (CRD) and the maximum score of 24 in Mini-Mental State Examination (MMSE).
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Either spouse had some severe disease (e.g. cancer) that might lead to institutionalisation or death in near future.

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)
The couples were recruited by newspaper announcements and from a compensation register for Alzheimer Disease drug costs of the Social Insurance Institution. Eligibility of couples were assessed by research nurses and further confirmed by researchers. Allocation was done by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation: blocked randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment outside Australia
Country [1] 504 0
Finland
State/province [1] 504 0

Funding & Sponsors
Funding source category [1] 1952 0
Charities/Societies/Foundations
Name [1] 1952 0
The Slot Machine Association of Finland
Country [1] 1952 0
Finland
Primary sponsor type
Charities/Societies/Foundations
Name
The Central Union for the Welfare of the Aged
Address
Malmin kauppatie 26 00700 Helsinki
Country
Finland
Secondary sponsor category [1] 1764 0
University
Name [1] 1764 0
University of Helsinki
Address [1] 1764 0
Pl Box 20, 00014 Helsingin yliopisto, Finland
Country [1] 1764 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3647 0
The Ethic Committee of the Helsinki University Hospital
Ethics committee address [1] 3647 0
Ethics committee country [1] 3647 0
Finland
Date submitted for ethics approval [1] 3647 0
Approval date [1] 3647 0
08/09/2003
Ethics approval number [1] 3647 0
400/ E5/ 03
Ethics committee name [2] 3648 0
The Ethic Committee of the Helsinki City
Ethics committee address [2] 3648 0
Ethics committee country [2] 3648 0
Finland
Date submitted for ethics approval [2] 3648 0
Approval date [2] 3648 0
06/09/2004
Ethics approval number [2] 3648 0
04-1184/ 054

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

Contacts
Principal investigator
Name 27782 0
Address 27782 0
Country 27782 0
Phone 27782 0
Fax 27782 0
Email 27782 0
Contact person for public queries
Name 10868 0
Ulla Eloniemi-Sulkava
Address 10868 0
The Central Union for the Welfare of the Aged
Malmin kauppatie 26
00700 Helsinki
Country 10868 0
Finland
Phone 10868 0
+358 9 350 8600
Fax 10868 0
+358 9 3508 6010
Email 10868 0
[email protected]
Contact person for scientific queries
Name 1796 0
Ulla Eloniemi-Sulkava
Address 1796 0
The Central Union for the Welfare of the Aged
Malmin kauppatie 26
00700 Helsinki
Country 1796 0
Finland
Phone 1796 0
+358 9 350 8600
Fax 1796 0
+358 9 3508 6010
Email 1796 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.