Try our beta test site

PVS: Innovative Programs For Healthy Lifestyle Promotion in Primary Care: 'Prescribe Healthy Life' (PVS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Basque Health Service
Sponsor:
Information provided by (Responsible Party):
Gonzalo Grandes, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01365026
First received: June 1, 2011
Last updated: January 30, 2017
Last verified: January 2017

June 1, 2011
January 30, 2017
January 6, 2016
December 31, 2017   (Final data collection date for primary outcome measure)
  • Health propmotion clinical practice change [ Time Frame: 12 months ]
    Rates and proportion of primary care attendees exposed to the 5 A's
  • Adoption by primary care attendees of the minimum recommended levels of physical activity, fruits and vegetable consumption and smoking abstinence [ Time Frame: 6 months ]
    Change in at least one and number of modified lifestyle behaviors
adoption of the minimum recommended levels of physical activity, fruits and vegetables consumption and smoking abstinence [ Time Frame: 12 months ]
Change in at least one and number of modified lifestyle behaviors
Complete list of historical versions of study NCT01365026 on ClinicalTrials.gov Archive Site
Efficiency of healthy lifestyle prescription [ Time Frame: 6 months ]
Costs and utility of the prescription of healthy behabior change plan
Perceived preventive practice [ Time Frame: 12 months ]
self reported change in preventive practices delivered by primary care professionals
Not Provided
Not Provided
 
PVS: Innovative Programs For Healthy Lifestyle Promotion in Primary Care: 'Prescribe Healthy Life'
Feasibility and Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)
The potential health gains from healthy lifestyles are very well-known, what is still not known is how to help people to adopt these lifestyles, by means of brief interventions feasible in routine general practice. This study was designed to explore the feasibility and efficacy of innovative implementation strategies for the promotion physical activity, diet and smoking abstinence in primary care. The investigators hypothesize that collegiate planning between practitioners, researchers and managers, with a socio-ecological perspective and taking into account the real context of collaborating centers, will guarantee the sustainability and effectiveness of these programs.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
  • Health Promotion
  • Health Education
  • Patient Education
  • Counseling
  • Behavior Therapy
  • Health Behavior
Behavioral: PVS: Programa de Vida Saludable
Lifestyle counseling and prescription
  • Experimental: PVS intervention
    Intervention: Behavioral: PVS: Programa de Vida Saludable
  • No Intervention: Control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4017
December 31, 2018
December 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 80 Years   (Child, Adult, Senior)
Yes
Contact: Gonzalo Grandes, MD, MS +34946006637 Gonzalo.Grandes@Osakidetza.net
Contact: Alvaro sanchez, PhD +34 946006637 alvaro.sanchez@osakidetza.net
Spain
 
 
NCT01365026
PS09/01461
2014111076 ( Other Grant/Funding Number: Basque Health Department )
PI13/00573 ( Other Grant/Funding Number: Carlos III Institute of Health, Spanish Ministry of Health )
RD12/0005/0010 ( Other Grant/Funding Number: Carlos III Institute of Health, Spanish Ministry of Health )
No
Not Provided
Not Provided
Not Provided
Gonzalo Grandes, Basque Health Service
Basque Health Service
Not Provided
Principal Investigator: Gonzalo Grandes, MD, MS Basque Health Service
Basque Health Service
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP