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Background  Educational initiatives for informal caregivers have proved efficient at reducing some of their symptoms, consequence of their involvement in care giving. However, more progress must be made in terms of the design of more successful interventions. Aims: Randomized clinical trial to test the efficiency of an Education Program for Primary Informal Caregivers of Hospitalized Dependent Patients in relation to their burden, mental and physical health, and care related knowledge.    Methods  Design: Cluster Randomized Trial. Sample: 151 participants, primary caregivers of hospitalized, dependent patients, carried out from February 2009 to March 2010. They were assigned at random to two groups: one received an intensive educational program (n = 78), and the other just a generic speech (n = 73). The degree of burden of caregivers was recorded (Zarit Test), as well as their physical and mental health (SF12) and their knowledge of caregiving, before, immediately, after and one and a half months after the intervention. These analyses were carried out according to the Generalized Estimated Equations Method, in order to assess any possible improvements.    Results  Participants´ burden did not improve, as measured by Zarit Test (p = 0,338), nor did their physical (p = 0,917) or mental health (p = 0,345). However there was an improvement in their hygiene caregiving (p = 0,001) and mobility care giving (p = 0,001).    Conclusions  Caregivers found useful the education program, providing them with an informal support group. Interventions need to be longer and more customized as well as adapted to specific demands. There is a lack of validated questionnaires to assess improvements in care knowledge. There is a need to develop programs that contemplate continuity of care from primary to specialized caregiving.    Trial registration  Cluster randomized trial:  ESCPD2010

Efficiency of an intensive educational program for informal caregivers of hospitalized, dependent patients: cluster randomized trial