Clinical trial NCT01177696: Intervention in Groups of Family Caregivers in Primary Health Care
Official title: VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
Keywords: caregivers
Family Health
Psychotherapeutic
Primary Health Care
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in caregivers will be the principal measure:
timeFrame: Initial and 6 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca.
country: Spain
facility: Primary care Research unit. La Alamedilla health centre
Study officials:
affiliation: La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
name: Rodriguez-Sanchez Emiliano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
name: Mora-Simón Sara
role: STUDY_CHAIR
affiliation: La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain.
name: Porras-Santos Nieves
role: STUDY_CHAIR
affiliation: Departamento de Estadística. Universidad de Salamanca. Salamanca. Spain.
name: Patino-Alonso M. Carmen, MD
role: STUDY_CHAIR
affiliation: La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
name: Recio-Rodríguez José-Ignacio
role: STUDY_CHAIR
affiliation: La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
name: Becerro-Muñoz Concepción, MD
role: STUDY_CHAIR
affiliation: La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
name: Pérez-Arachaederra Diana
role: STUDY_CHAIR
affiliation: La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
name: Gómez-Marcos Manuel-Ángel, md
role: STUDY_CHAIR
affiliation: La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
name: García Ortiz Luís, MD
role: STUDY_DIRECTOR
References:
citation: Rodriguez-Sanchez E, Mora-Simon S, Porras-Santos N, Patino-Alonso MC, Recio-Rodriguez JI, Becerro-Munoz C, Perez-Arechaederra D, Gomez-Marcos MA, Garcia-Ortiz L. Effectiveness of an intervention in groups of family caregivers of dependent patients for their application in primary health centers. Study protocol. BMC Public Health. 2010 Sep 17;10:559. doi: 10.1186/1471-2458-10-559.