Condition category
Not Applicable
Date applied
04/05/2007
Date assigned
19/09/2007
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

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

http://www.kela.fi/in/internet/english.nsf

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes