- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Gonzalo Grandes, MD, MS
- Numero di telefono: +34946006637
- Email: Gonzalo.Grandes@Osakidetza.net
Backup dei contatti dello studio
- Nome: Alvaro sanchez, PhD
- Numero di telefono: +34 946006637
- Email: alvaro.sanchez@osakidetza.net
Luoghi di studio
-
-
-
Bilbao, Spagna, E48014
- Reclutamento
- Primary care research unit of Bizkaia
-
Contatto:
- Gonzalo Grandes
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Gruppo di controllo
|
|
Sperimentale: PVS intervention
|
Lifestyle counseling and prescription
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Health propmotion clinical practice change
Lasso di tempo: 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
Lasso di tempo: 6 months
|
Change in at least one and number of modified lifestyle behaviors
|
6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Efficiency of healthy lifestyle prescription
Lasso di tempo: 6 months
|
Costs and utility of the prescription of healthy behabior change plan
|
6 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gonzalo Grandes, MD, MS, Basque Health Service
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- PS09/01461
- 2014111076 (Altro numero di sovvenzione/finanziamento: Basque Health Department)
- PI13/00573 (Altro numero di sovvenzione/finanziamento: Carlos III Institute of Health, Spanish Ministry of Health)
- RD12/0005/0010 (Altro numero di sovvenzione/finanziamento: Carlos III Institute of Health, Spanish Ministry of Health)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su La promozione della salute
-
University of Dublin, Trinity CollegeSconosciutoBrain Health Atleti d'élite in pensione
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... e altri collaboratoriAttivo, non reclutanteServizi Sanitari Preventivi (PREV HEALTH SERV)Stati Uniti
-
The Hospital for Sick ChildrenBill and Melinda Gates Foundation; Aga Khan UniversityAttivo, non reclutanteUnder Five Child Health Nutrizione e immunizzazionePakistan
-
Queens College, The City University of New YorkReclutamentoPubblicazione di articoli sottoposti all'American Journal of Public HealthStati Uniti
-
KTO Karatay UniversityCompletatoComportamenti di stile di vita sani | E-Health AlfabetizzazioneTacchino
-
Kliniek ViaSanaSt. Anna Ziekenhuis, Geldrop, NetherlandsCompletatoDolore | Uso di oppioidi | Sostituzione totale del ginocchio | App E-healthOlanda
-
Brown UniversityJohns Hopkins University; University of Arkansas; Anhui Medical UniversityCompletato
-
Yonsei UniversityCompletatoInfermieri che lavorano presso il Community Mental Health Welfare CenterCorea, Repubblica di
-
Istanbul University - Cerrahpasa (IUC)ReclutamentoCardiochirurgia, Cardiochirurgia, Educazione alla dimissione, Infermieristica, Telenursing, m-Health, Qualità della vita, RecuperoTacchino
-
Hospital Central Sur de Alta EspecialidadSconosciutoIctus | Scala dell'ictus del National Institutes of Health | Proteina C-reattiva ad alta sensibilità del sieroMessico