RT Journal Article
T1 Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.
A1 Zabaleta-Del-Olmo, Edurne
A1 Pombo, Haizea
A1 Pons-Vigués, Mariona
A1 Casajuana-Closas, Marc
A1 Pujol-Ribera, Enriqueta
A1 López-Jiménez, Tomás
A1 Cabezas-Peña, Carmen
A1 Martín-Borràs, Carme
A1 Serrano-Blanco, Antoni
A1 Rubio-Valera, Maria
A1 Llobera, Joan
A1 Leiva, Alfonso
A1 Vicens, Caterina
A1 Vidal, Clara
A1 Campiñez, Manuel
A1 Martín-Álvarez, Remedios
A1 Maderuelo, José-Ángel
A1 Recio, José-Ignacio
A1 García-Ortiz, Luis
A1 Motrico, Emma
A1 Bellón, Juan-Ángel
A1 Moreno-Peral, Patricia
A1 Martín-Cantera, Carlos
A1 Clavería, Ana
A1 Aldecoa-Landesa, Susana
A1 Magallón-Botaya, Rosa
A1 Bolíbar, Bonaventura
K1 Complex interventions
K1 Cost-effectiveness analysis
K1 Health behaviour
K1 Health promotion
K1 Hybrid trial
K1 Implementation research
K1 Mediterranean diet
K1 Physical activity
K1 Primary health care
K1 Smoking
AB Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.
YR 2018
FD 2018-07-13
LK http://hdl.handle.net/10668/12707
UL http://hdl.handle.net/10668/12707
LA en
DS RISalud
RD Mar 17, 2025