Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001173987
Ethics application status
Approved
Date submitted
1/11/2011
Date registered
10/11/2011
Date last updated
14/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of self-management skills enhancing rehabilitation on dementia patients and their spousal caregivers.
Scientific title
Effectiveness of self-management skills enhancing group rehabilitation on dementia patients' and their spousal caregivers' quality-of-life.
Secondary ID [1] 273295 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 279061 0
spousal caregiving 279062 0
Condition category
Condition code
Public Health 279253 279253 0 0
Health promotion/education
Neurological 279254 279254 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both caregivers and dementia patients in the intervention arm will be offered a group-based rehabilitation concurrently but in separate groups of 10 persons. These groups will consist only caregivers and only patients. They will meet four hours in a day center once a week over a total of 8 weeks. There are two professional group facilitators in each group. The facilitators have received thorough training.
Intervention will empower older people by encouraging them to bring up their wishes and aims of group work. The contents of the group discussions will be based on the preferences of the participants. The aim is to enhance agency of older people and their self-management skills. Intervention will take advantage of group dynamics, peer support.
The group facilitators will make one home-visit before the intervention to get to know the participants and to encourage them to express their needs and hopes for the intervention. Group intervention will be objective-oriented.
Intervention code [1] 283642 0
Behaviour
Comparator / control treatment
Written information sheets about exercise and nutrition will be given 3 and 9 months after randomisation.
Control group
Active

Outcomes
Primary outcome [1] 279875 0
Dementia patients' quality of life assessed with 15D measurement
Timepoint [1] 279875 0
Baseline, and at 3 and 9 months after radomisation
Primary outcome [2] 279876 0
Caregivers' quality of life assessed with RAND-36 measurement
Timepoint [2] 279876 0
Baseline, and at 3 and 9 months after randomisation
Primary outcome [3] 279877 0
Caregivers' sense of competence assessed with Sense of Competence Questionnaire (Vernooij-Dassen, 1993)
Timepoint [3] 279877 0
Baseline, and at 3 and 9 months after randomisation
Secondary outcome [1] 294653 0
Caregiver psychological well-being assessed with GHQ-12
Timepoint [1] 294653 0
Baseline, and at 3 and 9 months after randomization
Secondary outcome [2] 294654 0
Dementia patients' depression assessed withmean Cornell depression mean score
Timepoint [2] 294654 0
Baseline, and at 3 and 9 months after randomisation
Secondary outcome [3] 294655 0
Dementia patients' cognition assessed with clock drawing test and verbal flow test
Timepoint [3] 294655 0
Baseline, and at 3 and 9 months after randomisation
Secondary outcome [4] 294656 0
Caregivers' the feeling of self-efficacy assessed with (Pearl)
Timepoint [4] 294656 0
Baseline, and at 3 and 9 months after randomisation
Secondary outcome [5] 294657 0
Cargivers' psychological well-being (PWB score)
Timepoint [5] 294657 0
Baseline, and at 3 and 9 months after randomisation
Secondary outcome [6] 294658 0
Caregivers' depression assessed with CES-D mean score
Timepoint [6] 294658 0
Baseline, and at 3 and 9 months after randomisation
Secondary outcome [7] 294659 0
Dementia patients' and caregivers' use of health and social services and their costs assessed with data linkage to medical records
Timepoint [7] 294659 0
at 24 months
Secondary outcome [8] 294660 0
Dementia patients' time at home, insitutionalizations and mortality assessed with data linkage to medical records
Timepoint [8] 294660 0
At 24 months
Secondary outcome [9] 294661 0
Demenita patient self-reported feeling of illness assesed with Illness Cognition Questionnaire (Evers & Kraaimaat, 1998)
Timepoint [9] 294661 0
Baseline, and at 3 and 9 months after randomisation

Eligibility
Key inclusion criteria
-Finnish speaking
-spouse is living in the same address
-volunteer
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-unable to walk by themselves (with or without a walking aid)
- unable to hear a regular speech (with or without a hearing aid),
- terminal phase disease

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)
During years 2011-12 160 dementia patients and their spouses will be recruited from memory clinics and newspaper advertisement. The couples will be randomized in clusters of 20. After assessing 20 couples with eligibility criteria confirmed and agreeing to consent the study, the randomization will be performed by calling to randomisation unit where an outsider person will use the computer programm for the allocation. The allocation will be concealed by central randomisation using phone and computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Couples will be randomly allocated by means of computer-generated random numbers to two arms: to receive group-based intervention or to receive the usual care. The study nurse will call by telephone to a randomization staff member who has not seen the couples neither their clinical records. She will assign the next number from the computer and the group assignment to the patient.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
10/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 3936 0
Finland
State/province [1] 3936 0

Funding & Sponsors
Funding source category [1] 284121 0
Charities/Societies/Foundations
Name [1] 284121 0
Finnish Medical Society
Country [1] 284121 0
Finland
Funding source category [2] 284122 0
Hospital
Name [2] 284122 0
Helsinki University Hospital
Country [2] 284122 0
Finland
Funding source category [3] 284140 0
Other
Name [3] 284140 0
City of Helsinki, Health Center
Country [3] 284140 0
Finland
Primary sponsor type
University
Name
University of Helsinki
Address
Unit of General Practice
P.O.Box 20
00014 University of Helsinki
Country
Finland
Secondary sponsor category [1] 269085 0
Charities/Societies/Foundations
Name [1] 269085 0
The Central Union for the Welfare of the Aged
Address [1] 269085 0
Malmin kauppatie 26,
FI-00700 Helsinki
Country [1] 269085 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272082 0
Helsinki University Hospital
Ethics committee address [1] 272082 0
Ethics committee country [1] 272082 0
Finland
Date submitted for ethics approval [1] 272082 0
15/11/2010
Approval date [1] 272082 0
08/12/2010
Ethics approval number [1] 272082 0
340/13/03/01/10

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

Contacts
Principal investigator
Name 33328 0
Address 33328 0
Country 33328 0
Phone 33328 0
Fax 33328 0
Email 33328 0
Contact person for public queries
Name 16575 0
Marja-Liisa Laakkonen
Address 16575 0
Helsinki Health Center
Laakso Hospital
P.O.Box 6600
00099 The City of Helsinki
Country 16575 0
Finland
Phone 16575 0
+358505478616
Fax 16575 0
Email 16575 0
[email protected]
Contact person for scientific queries
Name 7503 0
Marja-Liisa Laakkonen
Address 7503 0
Helsinki Health Center
Laakso Hospital
P.O.Box 6600
00099 The City of Helsinki
Country 7503 0
Finland
Phone 7503 0
+358505478616
Fax 7503 0
Email 7503 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
SourceTitleYear of PublicationDOI
Dimensions AIPsychosocial group intervention to enhance self-management skills of people with dementia and their caregivers: study protocol for a randomized controlled trial2012https://doi.org/10.1186/1745-6215-13-133
EmbaseEffects of Self-Management Groups for People with Dementia and Their Spouses - Randomized Controlled Trial.2016https://dx.doi.org/10.1111/jgs.14055
N.B. These documents automatically identified may not have been verified by the study sponsor.