Contact information
Type
Scientific
Primary contact
Prof Olli-Pekka Ryynänen
ORCID ID
Contact details
University of Kuopio
Department of Public Health/General Practice
Mäkikatu 7
Kuopio
70100
Finland
+358 (0)405 14 17 41
ollipekka.ryynanen@uku.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
cg171201
Study information
Scientific title
Efficacy of a multicomponent support programme for caregivers of disabled persons: a randomised controlled study
Acronym
CAREGIVER
Study hypothesis
A tailored support programme for caregivers of the disabled persons is effective in helping them to continue their caregiving.
Ethics approval
Ethics approval received from the Ethical Committee of Kymenlaakso Central Hospital, Kotka on the 17th December 2001 (addition 17th February 2003).
Study design
A randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Caregiving of a disabled person
Intervention
Tailored two weeks training period in a rehabilitation centre, with tailored physical exercise, lessons about caregivers role to give psychological support and increase caregivers' knowledge and checking for medical treatments.
The control group received usual care.
The follow-up time was two years for mortality and continuation of caregiving, one year for quality of life and Zung's depression scale.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Mortality of the care receiver
2. Continuity of caregiving
3. Placement of the care receiver into an institutional care
Primary outcomes were measured at two years.
Secondary outcome measures
1. Health related quality of life of the caregiver (15D Measure of Health-Related Quality of Life)
2. Depressive symptoms of the caregiver (Zung's depression scale)
Secondary outcomes were measured at one year.
Overall trial start date
26/02/2003
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 135 caregiver - care receiver dyads randomly divided into an intervention group (n = 66) and a control group (n = 69)
2. Caregiver of a disabled adult person living in Kuusankoski and Kouvola region (south-east Finland)
3. Caregiving continued at least six months
4. Ability to leave the care receiver to temporary institutional care
5. Ability to live in spa-hotel conditions during the intervention
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
135
Total final enrolment
135
Participant exclusion criteria
1. Serious mental or physical disease of the caregiver
2. Caregiving only occasional
3. Not able to leave the care receiver
4. Not able to live in a spa-hotel during the intervention
Recruitment start date
26/02/2003
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Finland
Trial participating centre
University of Kuopio
Kuopio
70100
Finland
Sponsor information
Organisation
The Social Insurance Institution of Finland (KELA) (Finland)
Sponsor details
c/o Dr Paavo Rissanen
PO Box 450
Helsinki
00101
Finland
-
paavo.rissanen@kela.fi
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Social Insurance Institution of Finland (KELA) (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23743879 (added 11/06/2019)