Evidence map›Paper›PMID 30005705›Full record

Trial reportBMC public health2018

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.

Edurne Zabaleta-Del-Olmo, Haizea Pombo, Mariona Pons-Vigués, Marc Casajuana-Closas, Enriqueta Pujol-Ribera, Tomás López-Jiménez, Carmen Cabezas-Peña, Carme Martín-Borràs, Antoni Serrano-Blanco, Maria Rubio-Valera and 17 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC public health, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03136211 (A Hybrid Effectiveness-Implementation Trial of a Complex Multiple Risk Intervention to Promote Healthy Behaviors in People Between 45 to 75 Years Attended in Primary Health Care), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03136211 nacompletednot on this map

A Hybrid Effectiveness-Implementation Trial of a Complex Multiple Risk Intervention to Promote Healthy Behaviors in People Between 45 to 75 Years Attended in Primary Health Care

TypeinterventionalSponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaRan2017 to 2018Enrolled3,062ConditionsHealth Behavior, Health Promotion, Primary Health Care, Implementation ResearchArmsEIRA intervention
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Edurne Zabaleta-Del-OlmoInstitut Universitarid'Investigació en AtencióPrimària Jordi Gol (IDIAP Jordi Gol), Gran Via Corts Catalanes 587 àtic, 08007, Barcelona, Spain. ezabaleta@idiapjgol.org.ORCID 0000-0002-5072-8548
Haizea PomboPrimary Care Research Unit of Bizkaia, Basque Health Service-Osakidetza, Luis Power Kalea 18, 48014, Bilbao, Spain.
Mariona Pons-ViguésInstitut Universitarid'Investigació en AtencióPrimària Jordi Gol (IDIAP Jordi Gol), Gran Via Corts Catalanes 587 àtic, 08007, Barcelona, Spain.
Marc Casajuana-ClosasInstitut Universitarid'Investigació en AtencióPrimària Jordi Gol (IDIAP Jordi Gol), Gran Via Corts Catalanes 587 àtic, 08007, Barcelona, Spain.
Enriqueta Pujol-RiberaInstitut Universitarid'Investigació en AtencióPrimària Jordi Gol (IDIAP Jordi Gol), Gran Via Corts Catalanes 587 àtic, 08007, Barcelona, Spain.
Tomás López-JiménezInstitut Universitarid'Investigació en AtencióPrimària Jordi Gol (IDIAP Jordi Gol), Gran Via Corts Catalanes 587 àtic, 08007, Barcelona, Spain.
Carmen Cabezas-PeñaDeputy Directorate of Health Promotion, Public Health Agency, Department of Health, Goverment of Catalonia, Roc Boronat, 81-95 (Edifici Salvany), 08005, Barcelona, Spain.
Carme Martín-BorràsFaculty of Psychology, Education and Sport Sciences (FPCEE) Blanquerna, Ramon Llull University, C/Císter 34, 08022, Barcelona, Spain.
Antoni Serrano-BlancoParc SanitariSant Joan de Déu, Institut de Recerca Sant Joan de Déu, C/Santa Rosa 39-57, 08950, Esplugues de Llobregat, Spain.
Maria Rubio-ValeraParc SanitariSant Joan de Déu, Institut de Recerca Sant Joan de Déu, C/Santa Rosa 39-57, 08950, Esplugues de Llobregat, Spain.
Joan LloberaGerènciad'AtencióPrimària de Mallorca, Institut de InvestigacióSanitària de les Illes Balears IdISBa, C/Escola Graduada 3, 07002, Palma, Mallorca, Spain.
Alfonso LeivaGerènciad'AtencióPrimària de Mallorca, Institut de InvestigacióSanitària de les Illes Balears IdISBa, C/Escola Graduada 3, 07002, Palma, Mallorca, Spain.
Caterina VicensGerènciad'AtencióPrimària de Mallorca, Institut de InvestigacióSanitària de les Illes Balears IdISBa, C/Escola Graduada 3, 07002, Palma, Mallorca, Spain.
Clara VidalGerènciad'AtencióPrimària de Mallorca, Institut de InvestigacióSanitària de les Illes Balears IdISBa, C/Escola Graduada 3, 07002, Palma, Mallorca, Spain.
Manuel CampiñezPrimary Health Centre Vallcarca, Edificio Pedraforca, Av. Vallcarca 169-205, 08023, Barcelona, Spain.
Remedios Martín-ÁlvarezPrimary Health Centre Vallcarca, Edificio Pedraforca, Av. Vallcarca 169-205, 08023, Barcelona, Spain.
José-Ángel MaderueloInstitute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, La Alamedilla Health Center, Health Service of Castilla y León (SACyL), Avda. Comuneros 27-31, 37003, Salamanca, Spain.
José-Ignacio RecioInstitute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, La Alamedilla Health Center, Health Service of Castilla y León (SACyL), Avda. Comuneros 27-31, 37003, Salamanca, Spain.
Luis García-OrtizInstitute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, La Alamedilla Health Center, Health Service of Castilla y León (SACyL), Avda. Comuneros 27-31, 37003, Salamanca, Spain.
Emma MotricoPsychology Department, Universidad Loyola Andalucía, c/Energía Solar 1, Sevilla, Spain.
Juan-Ángel BellónResearch Unit, Primary Care District of Málaga-Guadalhorce, c/ Sevilla 23, Málaga, Spain.
Patricia Moreno-PeralResearch Unit, Primary Care District of Málaga-Guadalhorce, c/ Sevilla 23, Málaga, Spain.
Carlos Martín-CanteraInstitut Universitarid'Investigació en AtencióPrimària Jordi Gol (IDIAP Jordi Gol), Gran Via Corts Catalanes 587 àtic, 08007, Barcelona, Spain.
Ana ClaveríaGrupo I-Saúde, Instituto de Investigación Sanitaria Galicia-Sur (IISGS), Xerencia de Xestión Integrada de Vigo, ServizoGalego de Saúde (SERGAS), Universidade de Vigo, Avda Rosalía Castro 21, 36201, Vigo, Spain.
Susana Aldecoa-LandesaGrupo I-Saúde, Instituto de Investigación Sanitaria Galicia-Sur (IISGS), Xerencia de Xestión Integrada de Vigo, ServizoGalego de Saúde (SERGAS), Universidade de Vigo, Avda Rosalía Castro 21, 36201, Vigo, Spain.
Rosa Magallón-BotayaInstituto de Investigación Sanitaria Aragón, Avda. San Juan Bosco 13, 50009, Zaragoza, Spain.
Bonaventura BolíbarInstitut Universitarid'Investigació en AtencióPrimària Jordi Gol (IDIAP Jordi Gol), Gran Via Corts Catalanes 587 àtic, 08007, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHealth 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.

methodsThis 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. DISCUSSION: 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.

trial registrationClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

Indexed as

Health BehaviorPrimary Health CareAgedCost-Benefit AnalysisFemaleHealth PromotionHealth Risk BehaviorsHumansMaleMiddle AgedProgram EvaluationResearch DesignSpainSurveys and QuestionnairesComplex interventionsCost-effectiveness analysisHealth behaviourHealth promotionHybrid trialImplementation researchMediterranean dietPhysical activityPrimary health careSmoking

Identifiers

PMID30005705
PMCPMC6045838

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.