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

August 5, 2010 updated by: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca., Spain, 37003
        • Primary care Research unit. La Alamedilla health centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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 Names:
  • Received usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregivers will be the principal measure:
Time Frame: Initial and 6 months later
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.
Initial and 6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 9, 2010

Study Record Updates

Last Update Posted (Estimate)

August 9, 2010

Last Update Submitted That Met QC Criteria

August 5, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRS270A08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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