EFFICHRONIC study protocol: a non-controlled, multicentre European prospective study to measure the efficiency of a chronic disease self-management programme in socioeconomically vulnerable populations.

Introduction: More than 70% of world mortality is due to chronic conditions. Furthermore, it has been proven that social determinants have an enormous impact on both health-related behaviour and on the received attention from healthcare services. These determinants cause health inequalities. The objective of this study is to reduce the burden of chronic diseases in five European regions, hereby focusing on vulnerable populations, and to increase the sustainability of health systems by implementing a chronic disease self-management programme (CDSMP).

Methods And Analysis: 2000 people with chronic conditions or informal caregivers belonging to vulnerable populations, will be enrolled in the CDSMP in Spain, Italy, the UK, France and the Netherlands. Inclusion of patients will be based on geographical, socioeconomic and clinical stratification processes. The programme will be evaluated in terms of self-efficacy, quality of life and cost-effectiveness using a combination of validated questionnaires at baseline and 6 months from baseline.

Ethics And Dissemination: This study will follow the directives of the Helsinki Declaration and will adhere to the European Union General Data Protection Regulation. The project's activities, progress and outcomes will be disseminated via promotional materials, the use of mass media, online activities, presentations at events and scientific publications.

Trial Registration Number: ISRCTN70517103; Pre-results.