Contact information
Type
Scientific
Primary contact
Dr Manuel Martín-Carrasco
ORCID ID
Contact details
Egaña 10
Bilbao
E-48010
Spain
iip@fundacion-iip.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI08/90812
Study information
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
Acronym
EDUCA-II
Study hypothesis
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
The Ethical and Scientific Research Committe of Navarra, Spain, approved on August 5th 2008.
Study design
Two arm single blind multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2009
Overall trial end date
30/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
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).
Participant 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
Recruitment start date
01/09/2009
Recruitment end date
30/09/2010
Locations
Countries of recruitment
Portugal, Spain
Trial participating centre
Egaña 10
Bilbao
E-48010
Spain
Sponsor information
Organisation
Maria Josefa Recio Foundation - Institute of Psychiatric Research (Spain)
Sponsor details
Fundación Maria Josefa Recio - Instituto de Investigaciones Psiquiátricas
Egaña 10
Bilbao
E-48010
Spain
iip@fundacion-iip.org
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref:PI08/90812)
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: http://www.ncbi.nlm.nih.gov/pubmed/24113563
Publication citations
-
Results
Martín-Carrasco M, Domínguez-Panchón AI, González-Fraile E, Muñoz-Hermoso P, Ballesteros J, , Effectiveness of a psychoeducational intervention group program in the reduction of the burden experienced by caregivers of patients with dementia: the EDUCA-II randomized trial., Alzheimer Dis Assoc Disord, 28, 1, 79-87, doi: 10.1097/WAD.0000000000000003.