Efficacy of a multicomponent support programme for caregivers of disabled persons: a randomised controlled study
| ISRCTN | ISRCTN16401432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16401432 |
| Secondary identifying numbers | cg171201 |
- Submission date
- 04/05/2007
- Registration date
- 19/09/2007
- Last edited
- 11/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Olli-Pekka Ryynänen
Scientific
Scientific
University of Kuopio
Department of Public Health/General Practice
Mäkikatu 7
Kuopio
70100
Finland
| Phone | +358 (0)405 14 17 41 |
|---|---|
| ollipekka.ryynanen@uku.fi |
Study information
| Study design | A randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | Efficacy of a multicomponent support programme for caregivers of disabled persons: a randomised controlled study |
| Study acronym | CAREGIVER |
| Study objectives | A tailored support programme for caregivers of the disabled persons is effective in helping them to continue their caregiving. |
| Ethics approval(s) | Ethics approval received from the Ethical Committee of Kymenlaakso Central Hospital, Kotka on the 17th December 2001 (addition 17th February 2003). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 26/02/2003 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 135 |
| Total final enrolment | 135 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/02/2003 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Finland
Study participating centre
University of Kuopio
Kuopio
70100
Finland
70100
Finland
Sponsor information
The Social Insurance Institution of Finland (KELA) (Finland)
Government
Government
c/o Dr Paavo Rissanen
PO Box 450
Helsinki
00101
Finland
| paavo.rissanen@kela.fi | |
| Website | http://www.kela.fi/in/internet/english.nsf |
"ROR" |
https://ror.org/057yw0190 |
Funders
Funder type
Government
The Social Insurance Institution of Finland (KELA) (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | 11/06/2019 | Yes | No |
Editorial Notes
11/06/2019: Publication reference and total final enrolment added.
