Clinical trial NCT02373319: Self-screening of Cardiovascular Risk
Official title: Validity and Effectiveness of a Method for Self-screening of Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Factor, Cardiovascular
Keywords: Cardiovascular risk
Cholesterol
Hypertension
Diabetes
Smoking
Preventive Medicine
Epidemiology
Public Health
Diet
Physical Activity
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 960
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aims of this study are (1) to validate a self-screening method for cardiovascular (CV) risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From these data, the investigators will generate personalized recommendations based on the best available evidence. The investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases.

Detailed description: Primary prevention activities based on some admittedly blunt screening instruments such as cardiovascular (CV) risk functions must be addressed to the whole population, prioritizing certain sectors of the population. However, the main limitation of current risk screening procedures is related to the natural history of cardiovascular disease, whose expression depends on the cumulative exposure to cardiovascular risk factors throughout a person's lifetime. Early prevention of cardiovascular disease is key to reduce this cumulative risk, thereby reducing the incidence of cardiovascular events.

The objectives of this study are (1) to validate a self-screening method for cardiovascular risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From these data, the investigators will generate personalized recommendations based on the best available evidence. The investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases.

Cardiovascular risk measured with the self-screening method will be compared with the gold standard (cardiovascular risk supervised by health professional). Participants will be randomly assigned to the intervention (communication of cardiovascular risk and recommendation of personalized preventive actions) or control groups (communication of cardiovascular risk). Subjects will be reexamined one year after recruitment for assessing adherence to the preventive recommendations in terms of improvement in the control of cardiovascular risk factors.

Eligibility criteria: Inclusion Criteria:

* Understand and accept the study's procedures and sign an informed consent form
* Inhabitants of Girona (Gerona, Spain) and the metropolitan area

Exclusion Criteria:

* History of cardiovascular disease
* Individuals with terminal disease

Primary outcomes:
measure: Pre-post changes in blood lipid levels
timeFrame: [Time frame: From baseline to 12 months after the intervention]
Secondary outcomes:
measure: Pre-post changes in controlled blood lipid levels
timeFrame: From baseline to 12 months after the intervention
measure: Pre-post changes in controlled blood pressure
timeFrame: From baseline to 12 months after the intervention
measure: Pre-post changes in controlled body mass index
timeFrame: From baseline to 12 months after the intervention
measure: Pre-post differences in smoking status
timeFrame: From baseline to 12 months after the intervention
measure: Mean difference between two methods of cardiovascular risk estimation
timeFrame: From baseline to 30 minutes
measure: Pre-post changes in blood pressure
timeFrame: From baseline to 12 months after the intervention
measure: Pre-post changes in body mass index
timeFrame: From baseline to 12 months after the intervention
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol
Study officials:
affiliation: IMIM
name: Maria Grau, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: IMIM
name: Jaume Marrugat, MD, PhD
role: STUDY_DIRECTOR
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citation: Barroso M, Zomeno MD, Diaz JL, Perez S, Marti-Lluch R, Cordon F, Ramos R, Cabezas C, Salvador G, Castell C, Schroder H, Grau M. Efficacy of tailored recommendations to promote healthy lifestyles: a post hoc analysis of a randomized controlled trial. Transl Behav Med. 2021 Aug 13;11(8):1548-1557. doi: 10.1093/tbm/ibab035.
citation: Barroso M, Perez-Fernandez S, Vila MM, Zomeno MD, Marti-Lluch R, Cordon F, Ramos R, Elosua R, Degano IR, Fito M, Cabezas C, Salvador G, Castell C, Grau M. Validity of a method for the self-screening of cardiovascular risk. Clin Epidemiol. 2018 May 10;10:549-560. doi: 10.2147/CLEP.S158358. eCollection 2018.