Background: 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.
Methods/design: 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.
Discussion: 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 ClinicalTrials.gov under code number NCT 01478295.
Trial registration: ClinicalTrials.gov NCT01478295.