- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01365026
PVS: Innovative Programs For Healthy Lifestyle Promotion in Primary Care: 'Prescribe Healthy Life' (PVS)
Feasibility and Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
BACKGROUND: Primary health care (PHC) services have special opportunities for healthy lifestyles promotion. Yet, despite its potential impact health promotion is not widespread and the results obtained are limited.
OBJECTIVE: To explore the feasibility and efficacy of an implementation strategy for optimizing the promotion of physical activity, diet and smoking abstinence in PHC. The strategy is innovative for its collegiate planning between practitioners, researchers and managers, with a socio-ecological perspective and taking into account the real context of collaborating centers.
DESIGN AND LOCATION: quasi-experimental hybrid implementation-effectiveness trial, conducted in 6 PHC centers (20 practices in 3 intervention centers and 21 in 3 control centers), with the collaboration of the majority of primary care professionals within each center, and the participation of 4017 attendees randomly selected from the target population. INTERVENTION CENTRES: Each of the intervention centers will be exposed to the PVS multicomponent implementation strategy, including training, information and communication electronic tools integrated into the electronic clinical record (ECR), local leadership, creation of a community of practice, practice facilitation, and audit and feed-back for the implementation of an intervention program to promote multiple healthy lifestyles (physical activity, healthy diet, and smoking cessation), based on the 5A's (Ask, Advise, Agree, Assist and Arrange follow-up), and modeled by professionals in each intervention center, according to their organizational context and available community resources and agents.
CONTROL CENTRES: will receive the same training and dissemination of clinical guidelines, electronic support tools integrated into the ECR, audit and feed-back.
MEASUREMENTS: Programs' implementation will be evaluated in terms of reach, adoption, implementation and acceptability by PHC staff, following the RE-AIM framework. PHC attendees will be followed with 2 repeated measurements at baseline, and 6 months to estimate change in patients' adoption of the minimum recommended level of healthy lifestyles.
ANALYSIS: the investigators will compare the implementation rate of health promotion activities in intervention and control centers, the proportion of users exposed to the 5 A's and the observed change in users' healthy lifestyles. Centers with different intensities of actual implementation will be compared to explore characteristics associated with implementation and the interaction between implementation strategies and clinical effectiveness of the intervention programs.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Bilbao, Espagne, E48014
- Recrutement
- Primary Care Research Unit of Bizkaia
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Contact:
- Gonzalo Grandes
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- primary care attendees not meeting at least one of the healthy lifestyles recommendations
- 10 to 80 years old
Exclusion Criteria:
- psychotic mental disorders
- brain degenerative disorders
- mental retardation
- cognitive impairment
- dementia
- end of life
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Groupe de contrôle
|
|
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Expérimental: PVS intervention
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Lifestyle counseling and prescription
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Health propmotion clinical practice change
Délai: 12 months
|
Rates and proportion of primary care attendees exposed to the 5 A's
|
12 months
|
|
Adoption by primary care attendees of the minimum recommended levels of physical activity, fruits and vegetable consumption and smoking abstinence
Délai: 6 months
|
Change in at least one and number of modified lifestyle behaviors
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Efficiency of healthy lifestyle prescription
Délai: 6 months
|
Costs and utility of the prescription of healthy behabior change plan
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gonzalo Grandes, MD, MS, Basque Health Service
Publications et liens utiles
Publications générales
- Grandes G, Sanchez A, Sanchez-Pinilla RO, Torcal J, Montoya I, Lizarraga K, Serra J; PEPAF Group. Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009 Apr 13;169(7):694-701. doi: 10.1001/archinternmed.2009.23.
- Sanchez A, Grandes G, Cortada JM, Pombo H, Balague L, Calderon C. Modelling innovative interventions for optimising healthy lifestyle promotion in primary health care: "prescribe Vida Saludable" phase I research protocol. BMC Health Serv Res. 2009 Jun 18;9:103. doi: 10.1186/1472-6963-9-103.
- Grandes G, Sanchez A, Cortada JM, Balague L, Calderon C, Arrazola A, Vergara I, Millan E; Prescribe Vida Saludable group. Is integration of healthy lifestyle promotion into primary care feasible? Discussion and consensus sessions between clinicians and researchers. BMC Health Serv Res. 2008 Oct 14;8:213. doi: 10.1186/1472-6963-8-213.
- Grandes G, Sanchez A, Torcal J, Sanchez-Pinilla RO, Lizarraga K, Serra J; PEPAF Group. Targeting physical activity promotion in general practice: characteristics of inactive patients and willingness to change. BMC Public Health. 2008 May 22;8:172. doi: 10.1186/1471-2458-8-172.
- Zuazagoitia A, Montoya I, Grandes G, Arietaleanizbeascoa MS, Arce V, Martinez V, Sanchez M, Sanchez A. Reliability and validity of the 7-day Physical Activity Recall interview in a Spanish population. Eur J Sport Sci. 2014;14 Suppl 1:S361-8. doi: 10.1080/17461391.2012.705332. Epub 2012 Jul 25.
- Sanchez A, Grandes G, Ortega Sanchez-Pinilla R, Torcal J, Montoya I; PEPAF Group. Predictors of long-term change of a physical activity promotion programme in primary care. BMC Public Health. 2014 Feb 4;14:108. doi: 10.1186/1471-2458-14-108.
- Sanchez A, Bully P, Martinez C, Grandes G. Effectiveness of physical activity promotion interventions in primary care: A review of reviews. Prev Med. 2015 Jul;76 Suppl:S56-67. doi: 10.1016/j.ypmed.2014.09.012. Epub 2014 Sep 26.
- Bully P, Sanchez A, Zabaleta-del-Olmo E, Pombo H, Grandes G. Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: A systematic review. Prev Med. 2015 Jul;76 Suppl:S76-93. doi: 10.1016/j.ypmed.2014.12.020. Epub 2015 Jan 5.
- Sanchez A, Silvestre C, Campo N, Grandes G; PreDE research group. Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study. Trials. 2016 May 20;17(1):254. doi: 10.1186/s13063-016-1379-0.
- Bully P, Sanchez A, Grandes G, Pombo H, Arietalenizbeaskoa MS, Arce V, Martinez C; PVS Group. Metric properties of the "prescribe healthy life" screening questionnaire to detect healthy behaviors: a cross-sectional pilot study. BMC Public Health. 2016 Dec 7;16(1):1228. doi: 10.1186/s12889-016-3898-8.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PS09/01461
- 2014111076 (Autre subvention/numéro de financement: Basque Health Department)
- PI13/00573 (Autre subvention/numéro de financement: Carlos III Institute of Health, Spanish Ministry of Health)
- RD12/0005/0010 (Autre subvention/numéro de financement: Carlos III Institute of Health, Spanish Ministry of Health)
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