Efficacy of a psychoeducative intervention program to prevent or reduce the burden associated with caring for dementia patients
| ISRCTN | ISRCTN14411440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14411440 |
| Secondary identifying numbers | PI08/90812 |
- Submission date
- 18/02/2011
- Registration date
- 10/03/2011
- Last edited
- 29/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Manuel Martín-Carrasco
Scientific
Scientific
Egaña 10
Bilbao
E-48010
Spain
| iip@fundacion-iip.org |
Study information
| Study design | Two arm single blind multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of a psychoeducative intervention program to prevent or reduce the burden associated with caring for dementia patients: a two arm single blind, multicentre, randomised controlled trial |
| Study acronym | EDUCA-II |
| Study objectives | 1. The caregivers allocated to the psychoeducative intervention program will present less burden at endpoint (4 months) than the caregivers allocated to the control condition. 2. The caregivers allocated to the psychoeducative intervention program will present better mental health at endpoint (4 months) than the caregivers allocated to the control condition. 3. The caregivers allocated to the psychoeducative intervention program will present better quality of life at endpoint (4 months) than the caregivers allocated to the control condition. |
| Ethics approval(s) | The Ethical and Scientific Research Committe of Navarra, Spain, approved on August 5th 2008. |
| Health condition(s) or problem(s) studied | Burden associated to dementia caregiving |
| Intervention | Control group: Caregivers allocated to this group received the usual support from the day center or memory clinic where the patients had a multifaceted /multiprofessional care which aimed at reducing the rate of cognitive decline (cognitive stimulation groups) and improve or maintain as long as possible daily abilities (occupational therapy). The caregiver received periodical interviews and information about the situation and clinical course of the patient. Intervention group: Caregivers allocated to this group were exposed to the same usual care the control group received plus a psychoeducative intervention program. This intervention was administered in 7 group sessions of 90 minutes each and the sessions were administered 2 weeks apart. The caregiver received standardised information about the clinical course of dementia and training on different cognitive and behavioural skills to increase her care abilities, communicative skills and relaxation. |
| Intervention type | Other |
| Primary outcome measure | Change since baseline to endpoint in the caregiver burden as assessed by the Zarit Burden Interview |
| Secondary outcome measures | 1. Change since baseline to endpoint in the caregiver mental health as assessed by the General Health Questionnaire, 28 items 2. Change since baseline to endpoint in the caregiver quality of life as assessed by the SF-12 |
| Overall study start date | 01/09/2009 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | An anticipated number of 200 caregivers were estimated to attain 85% power. The trial recruited 238 caregivers (115 randomised to the intervention arm, 123 randomised to the control arm). |
| Key inclusion criteria | 1. Males or females with age more than or equal to 18 years, giving care to a familiar person with a diagnosis of dementia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV)-TR criteria 2. The caregiver was not profesionally paid for caregiving 3. The familiar diagnosed of dementia was receiving appropriate care as outpatient in a day center or memory clinic 4. The caregiver spend a minimum of 4 hours/day to care for the patient with dementia 5. The patient cared for had at least two instrumental activities impaired (a score of 0 in the Lawton & Brody scale) or one activity of daily life impaired (Katz index codes A or D) 6. Signed informed consent to participate in the trial |
| Key exclusion criteria | 1. Caregivers without time to attend the psychoeducative intervention training 2. Caregivers receiving currently or recently (last year), any standardised psychoeducative intervention similar to the one administered in the trial |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- Portugal
- Spain
Study participating centre
Egaña 10
Bilbao
E-48010
Spain
E-48010
Spain
Sponsor information
Maria Josefa Recio Foundation - Institute of Psychiatric Research (Spain)
Government
Government
Fundación Maria Josefa Recio - Instituto de Investigaciones Psiquiátricas
Egaña 10
Bilbao
E-48010
Spain
| iip@fundacion-iip.org |
Funders
Funder type
Government
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref:PI08/90812)
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 | 01/01/2013 | Yes | No |
