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Open Access Study protocol

CuidaCare: effectiveness of a nursing intervention on the quality of life’s caregiver: cluster-randomized clinical trial

Milagros Rico-Blázquez123*, Esperanza Escortell-Mayor12, Isabel del-Cura-González124, Teresa Sanz-Cuesta12, Pilar Gallego-Berciano5, Gonzalo de las Casas-Cámara6, Sonia Soto-Díaz27, Petra García-Sanz8, Natalie Harris-de-la-Vega9, María Martín-Martín8, Lorena Domínguez-Pérez10, Araceli Rivera-Álvarez11, Juan Antonio Sarrión-Bravo11, Concepción Pérez-de-Hita11, Marisol de-Frías-Redondo11, Carmen Ferrer-Arnedo12, Montserrat Hernández-Pascual13, Antonio Valdivia-Pérez14 and Yolanda Ramallo Fariña152

Author Affiliations

1 Unidad de Apoyo a la Investigación. Dirección Técnica de Docencia e Investigación. Gerencia Adjunta de Planificación y Calidad. Gerencia de Atención Primaria, C/ San Martín de Porres, 6 _ 5ª planta, 28035 Madrid, Spain

2 Investigadora de la Red de Investigación en Servicios Sanitarios de Salud y en Enfermedades Crónicas (REDISSEC), Madrid, Spain

3 Facultad de Enfermería, Universidad de Alcalá, Alcalá de Henares, Spain

4 Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Madrid, Spain

5 Unidad Docente de Medicina Preventiva y Salud Pública. Comunidad de Madrid, Hospital Universitario de La Princesa, Diego de León, 62, Madrid 28006 Spain

6 FEA Medicina Preventiva y Salud Pública, Hospital Universitario General de Castellón, Av Benicasim, Castellón de la Plana 12004 Spain

7 Unidad Docente Multiprofesional Oeste, Servicio Madrileño de Salud, Calle Alonso Cano, 8, Mostoles 28933, Spain

8 Centro de Salud Juncal, Servicio Madrileño de Salud, Avda. Madrid /Esq. Brasil, 39, Torrejón de Ardoz 28850, Spain

9 Centro de Salud La Veredilla, Servicio Madrileño de Salud, C/ Turin, 37, Torrejón de Ardoz 28850, Spain

10 Centro de Salud Miguel de Cervantes, Servicio Madrileño de Salud, Avda. Gustavo Adolfo Bécquer n°23, Alcalá de Henares 28, Spain

11 Dirección Asistencial Este Atención Primaria, Servicio Madrileño de Salud, C/ Nuestra Señora del Pilar, s/n, Alcalá de Henares 28803, Spain

12 Gerencia Hospital de Guadarrama, Servicio Madrileño de Salud, Avda. del Molino del Rey, 2, Guadarrama 28440, Spain

13 Dirección Técnica de Sistemas de Información Sanitaria de la Gerencia de Atención Primaria, Servicio Madrileño de Salud Salud, Calle O’Donnell 55, Madrid 28009, Spain

14 Unidad de Medicina Preventiva, Hospital de Dénia-Marina Salud, Ptda de Beniadlá s/n, Dénia 03700, Spain

15 FUNCIS: Fundación Canaria de Investigación y Salud, (Camino Candelaria, 44), Tenerife, (38109), Spain. Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain

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BMC Nursing 2014, 13:2  doi:10.1186/1472-6955-13-2

Published: 27 January 2014



In Spain, family is the main source of care for dependent people. Numerous studies suggest that providing informal (unpaid) care during a prolonged period of time results in a morbidity-generating burden. Caregivers constitute a high-risk group that experiences elevated stress levels, which reduce their quality of life.

Different strategies have been proposed to improve management of this phenomenon in order to minimize its impact, but definitive conclusions regarding their effectiveness are lacking.


A community clinical trial is proposed, with a 1-year follow-up period, that is multicentric, controlled, parallel, and with randomized allocation of clusters in 20 health care centers within the Community of Madrid. The study's objective is to evaluate the effectiveness of a standard care intervention in primary health care (intervention CuidaCare) to improve the quality of life of the caregivers, measured at 0, 6, and 12 months after the intervention.

One hundred and forty two subjects (71 from each group) ≥65 years, identified by the nurse as the main caregivers, and who provide consent to participate in the study will be included.

The main outcome variable will be perceived quality of life as measured by the Visual Analogue Scale (VAS) of EuroQol-5D (EQ-5D). The secondary outcome variables will be EQ-5D Dimensions, EQ-5D Index, nursing diagnosis, and Zarit's test. Prognostic variables will be recorded for the dependent patient and the caregiver.

The principle analysis will be done by comparing the average change in EQ-5D VAS value before and after intervention between the two groups. All statistical tests will be performed as intention-to-treat. Prognostic factors' estimates will be adjusted by mixed-effects regression models. Possible confounding or effect-modifying factors will be taken into account.


Assistance for the caregiver should be integrated into primary care services. In order to do so, incorporating standard, effective interventions with relevant outcome variables such as quality of life is necessary. Community care nurses are at a privileged position to develop interventions like the proposed one.

Trial registration

This trial has been registered in under code number NCT 01478295.

Caregivers; Nursing; Primary care; Quality of life; Social support; Psychological adaptation; Caregiver burden