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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
  Purpose
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.

Condition Intervention
Health Promotion
Health Education
Patient Education
Counseling
Behavior Therapy
Health Behavior
Behavioral: PVS: Programa de Vida Saludable

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Feasibility and Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Efficiency of healthy lifestyle prescription [ Time Frame: 6 months ]
    Costs and utility of the prescription of healthy behabior change plan


Estimated Enrollment: 4017
Actual Study Start Date: January 6, 2016
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVS intervention Behavioral: PVS: Programa de Vida Saludable
Lifestyle counseling and prescription
No Intervention: Control group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365026

Contacts
Contact: Gonzalo Grandes, MD, MS +34946006637 Gonzalo.Grandes@Osakidetza.net
Contact: Alvaro sanchez, PhD +34 946006637 alvaro.sanchez@osakidetza.net

Locations
Spain
Primary Care Research Unit of Bizkaia Recruiting
Bilbao, Spain, E48014
Contact: Gonzalo Grandes         
Sponsors and Collaborators
Basque Health Service
Investigators
Principal Investigator: Gonzalo Grandes, MD, MS Basque Health Service
  More Information

Publications:

Responsible Party: Gonzalo Grandes, MD, MS Epidemiology, Basque Health Service
ClinicalTrials.gov Identifier: NCT01365026     History of Changes
Other Study ID Numbers: 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 )
Study First Received: June 1, 2011
Last Updated: January 30, 2017

Keywords provided by Basque Health Service:
Healthy Lifestyle
Health promotion
Counselling
Action Plan
Primary Health Care

ClinicalTrials.gov processed this record on April 28, 2017