PVS: Innovative Programs For Healthy Lifestyle Promotion in Primary Care: 'Prescribe Healthy Life' (PVS)
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|ClinicalTrials.gov Identifier: NCT01365026|
Recruitment Status : Recruiting
First Posted : June 3, 2011
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Health Promotion Health Education Patient Education Counseling Behavior Therapy Health Behavior||Behavioral: PVS: Programa de Vida Saludable||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4017 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Feasibility and Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)|
|Actual Study Start Date :||January 6, 2016|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2018|
|Experimental: PVS intervention||
Behavioral: PVS: Programa de Vida Saludable
Lifestyle counseling and prescription
|No Intervention: Control group|
- 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
- Efficiency of healthy lifestyle prescription [ Time Frame: 6 months ]Costs and utility of the prescription of healthy behabior change plan
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365026
|Contact: Gonzalo Grandes, MD, MS||+34946006637||Gonzalo.Grandes@Osakidetza.net|
|Contact: Alvaro sanchez, PhD||+34 firstname.lastname@example.org|
|Primary Care Research Unit of Bizkaia||Recruiting|
|Bilbao, Spain, E48014|
|Contact: Gonzalo Grandes|
|Principal Investigator:||Gonzalo Grandes, MD, MS||Basque Health Service|