PVS: Innovative Programs For Healthy Lifestyle Promotion in Primary Care: 'Prescribe Healthy Life'
NCT ID: NCT01365026
Last Updated: 2017-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4017 participants
INTERVENTIONAL
2016-01-06
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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PVS intervention
PVS: Programa de Vida Saludable
Lifestyle counseling and prescription
Control group
No interventions assigned to this group
Interventions
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PVS: Programa de Vida Saludable
Lifestyle counseling and prescription
Eligibility Criteria
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Inclusion Criteria
* 10 to 80 years old
Exclusion Criteria
* brain degenerative disorders
* mental retardation
* cognitive impairment
* dementia
* end of life
10 Years
80 Years
ALL
Yes
Sponsors
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Basque Health Service
OTHER_GOV
Responsible Party
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Gonzalo Grandes
MD, MS Epidemiology
Principal Investigators
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Gonzalo Grandes, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Basque Health Service
Locations
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Primary Care Research Unit of Bizkaia
Bilbao, , Spain
Countries
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Central Contacts
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Facility Contacts
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Gonzalo Grandes
Role: primary
References
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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, 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.
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.
Other Identifiers
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2014111076
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PI13/00573
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RD12/0005/0010
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PS09/01461
Identifier Type: -
Identifier Source: org_study_id
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