Condition category
Nervous System Diseases
Date applied
18/02/2011
Date assigned
10/03/2011
Last edited
29/10/2013
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

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 measures

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24113563

Publication citations

  1. 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.

Additional files

Editorial Notes