Intervention in Groups of Family Caregivers in Primary Health Care (IGFC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Fundacion para la Investigacion y Formacion en Ciencias de la Salud.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier:
NCT01177696
First received: July 30, 2010
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. However, these interventions are the ones that achieve better results to reduce symptomatology and improve emotional state of caregivers.

The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health and quality of life of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.

To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly face the care.


Condition Intervention
Mental Health
Behavioral: Psychotherapeutic intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE.

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:

Primary Outcome Measures:
  • Change in caregivers will be the principal measure: [ Time Frame: Initial and 6 months later ] [ Designated as safety issue: No ]
    family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring.


Estimated Enrollment: 150
Study Start Date: September 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: psychotherapy

The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health of caregivers.

This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.

Behavioral: Psychotherapeutic intervention
A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.
Other Name: Received usual care.
No Intervention: Control

Detailed Description:

Methods/Design: Design: This is multicentre cross-sectional study, randomized in two parallel groups.

Setting: Two different urban PHC. Study population: 150 caregivers will be included by consecutive sampling. They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers. Of chance form 100 caregivers will be assigned to the experimental group and 50 to the group control.

Measurements: Each caregiver will be evaluated on a personal interview. The caregivers' assessment protocol: 1) Assessment of different socio-demographic related to care, and caregiver's personal situation. 2)Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ). 3)Change in caregivers will be the principal measure: family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring. 4) Intervention implementation measures will also be assessed.

Intervention: A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.

Discussion: Psychotherapeutic interventions have been proved to obtain better results to reduce symptomatology and improve emotional state of caregivers. Moreover, this intervention has been proved to be effective in a different setting other than PHC, and was developed by professionals of Mental Health. If we found that this intervention is effective in PHC and with our professionals, it would be an important instrument to offer to caregivers of care-dependent patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Caregivers: They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers

Exclusion Criteria:

  • Those persons who did not share their place of residence with the relative, or who were impossible to locate either due to a change of address or being admitted to hospital or a nursing home, or on account of the patient's death were excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177696

Locations
Spain
Primary care Research unit. La Alamedilla health centre
Salamanca., Spain, 37003
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Investigators
Principal Investigator: Rodriguez-Sanchez Emiliano, MD La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
Study Chair: Mora-Simón Sara La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
Study Chair: Porras-Santos Nieves La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain.
Study Chair: Patino-Alonso M. Carmen, MD Departamento de Estadística. Universidad de Salamanca. Salamanca. Spain.
Study Chair: Recio-Rodríguez José-Ignacio La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
Study Chair: Becerro-Muñoz Concepción, MD La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
Study Chair: Pérez-Arachaederra Diana La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
Study Chair: Gómez-Marcos Manuel-Ángel, md La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
Study Director: García Ortiz Luís, MD La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  More Information

Additional Information:
No publications provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT01177696     History of Changes
Other Study ID Numbers: GRS270A08
Study First Received: July 30, 2010
Last Updated: August 5, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
caregivers
Family Health
Psychotherapeutic
Primary Health Care

Additional relevant MeSH terms:
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014