Community Blood Pressure Screening and Cardiovascular Risk Assessment in Croatia (BPSCREEN-CRO)

A Prospective Observational Study of Blood Pressure Values, Antihypertensive Medication Use and Cardiovascular Risk Factors Among Adults Attending Community-Based Public Health Screening Campaigns in Croatia

This is a prospective, observational, non-interventional study conducted during community-based public health blood pressure screening campaigns in Croatia. Adult participants who voluntarily attend public health actions will be invited to complete a short questionnaire on demographics, known cardiovascular risk factors, medical history and medication use. Blood pressure and pulse will be measured using validated blood pressure monitors. The study will assess the prevalence of elevated blood pressure, known and potentially undiagnosed hypertension, antihypertensive treatment patterns and cardiovascular risk factors. Participants may optionally consent to short-term follow-up by telephone or e-mail after 1 to 3 months to collect information on repeated blood pressure measurement, physician consultation, additional evaluation, new diagnosis of hypertension or medication change. The study does not include treatment allocation, prescribing or modification of therapy by the research team.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Cardiovascular Risk Factors
• Intervention / Treatment: Other: Blood pressure measurement and questionnaire-based data collection

Detailed Description

This prospective, observational, non-interventional study will be conducted during community-based public health blood pressure screening campaigns in Croatia. The primary objective is to determine the prevalence of elevated blood pressure among adults attending these screening activities and to describe previously diagnosed hypertension, antihypertensive medication use and associated cardiovascular risk factors.

Adults aged 18 years or older who voluntarily attend the screening activities will be invited to participate. After providing written informed consent, participants will complete a structured questionnaire including demographic characteristics, known cardiovascular risk factors, relevant medical history, current medication use and selected lifestyle factors.

Blood pressure and pulse will be measured in a seated position, after an appropriate resting period, using validated blood pressure monitors and a cuff appropriate for the participant's arm circumference. Three consecutive measurements are planned, with a short interval between measurements. For statistical analysis and classification of blood pressure values, the average of the last two available measurements will be used. If three measurements are available, the average of the second and third measurements will be calculated. If only two measurements are available, the average of the first and second measurements will be used.

Elevated blood pressure and blood pressure values in the hypertension range will be classified according to the prespecified definitions stated in the study protocol. A single elevated blood pressure measurement obtained during a public health screening campaign will not be considered sufficient to establish a diagnosis of arterial hypertension.

The study is non-interventional. The research team will not assign treatment, prescribe medication or modify existing therapy. Participants will receive information about their measured blood pressure values and general advice to repeat blood pressure measurements or contact their family physician or another healthcare professional when indicated by the measured values, reported symptoms or clinical judgment.

Participants who consent to optional short-term follow-up may be contacted by telephone or email 1 to 3 months after the baseline screening visit. Follow-up information will include whether the participant repeated blood pressure measurements, consulted a physician, underwent additional diagnostic evaluation, received a new diagnosis of hypertension or had a change in antihypertensive treatment. Participation in follow-up is voluntary and is not required for participation in the baseline screening component of the study.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Katica Cvitkušić Lukenda, MD, PhD; Phone Number: +38598556576; Email: kclukenda@gmail.com

Study Locations

• Croatia
  • Brod-Posavina County
    • Slavonski Brod, Brod-Posavina County, Croatia, 35000
      • General Hospital Dr. Josip Bencevic
      • Contact: Katica Cvitkušić Lukenda, MD, PhD; Phone Number: +38598556576; Email: kclukenda@gmail.com
      • Contact: Email: kclukenda@gmail.com
      • Principal Investigator: Katica Cvitkušić Lukenda, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older who voluntarily attend community-based public health blood pressure screening campaigns in Croatia and provide informed consent for participation. Participants may include individuals with or without previously diagnosed hypertension and with or without current antihypertensive treatment. The study population will be recruited from the general adult population attending public health screening activities.

Description

Inclusion Criteria:

• Age 18 years or older
• Voluntary attendance at a community-based public health blood pressure screening campaign
• Ability to understand the study information
• Signed informed consent for participation in the baseline observational study

Exclusion Criteria:

• Age under 18 years
• Inability or unwillingness to provide informed consent
• Incomplete baseline blood pressure data preventing assessment of the primary outcome
• Acute medical condition requiring immediate emergency evaluation before completion of study procedures, at the discretion of the research team

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Community screening participants; Adults attending community-based public health blood pressure screening campaigns who provide informed consent and undergo questionnaire-based data collection and blood pressure measurement. Participants may optionally consent to short-term follow-up by telephone or email 1 to 3 months after the baseline screening visit.

Other: Blood pressure measurement and questionnaire-based data collection; Non-interventional measurement of blood pressure and pulse using validated blood pressure monitors, together with questionnaire-based collection of demographic characteristics, cardiovascular risk factors, medical history, medication use and lifestyle factors. No treatment is assigned, prescribed or modified by the research team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of elevated blood pressure among adults attending community-based public health screening campaigns	The proportion of participants with an average systolic blood pressure of 140 millimeters of mercury (mmHg) or higher and/or an average diastolic blood pressure of 90 mmHg or higher at the baseline screening visit. Blood pressure will be calculated as the average of the last two available measurements. If three measurements are obtained, the average of the second and third measurements will be used. If only two measurements are available, the average of the first and second measurements will be used.	Baseline screening visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with previously known hypertension	Proportion of participants who self-report a previous diagnosis of arterial hypertension.	Baseline screening visit
Proportion of participants receiving antihypertensive medication	Proportion of participants who report current use of antihypertensive medication.	Baseline screening visit
Proportion of treated participants with elevated blood pressure at screening	Proportion of participants receiving antihypertensive medication who have elevated blood pressure based on the average of the last two available measurements at the baseline screening visit.	Baseline screening visit
Prevalence of cardiovascular risk factors	Proportion of participants reporting cardiovascular risk factors, including smoking, diabetes mellitus, dyslipidemia, obesity, chronic kidney disease and previous cardiovascular disease.	Baseline screening visit
Proportion of participants advised to contact a physician	Proportion of participants advised to contact their family physician or another healthcare professional based on measured blood pressure values, reported symptoms or clinical judgment during the public health screening action.	Baseline screening visit
Distribution of antihypertensive medication classes	Distribution of reported antihypertensive medication classes, including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium channel blockers, diuretics, mineralocorticoid receptor antagonists and other antihypertensive medications.	Baseline screening visit
Follow-up outcomes among participants consenting to short-term follow-up	Among participants who consent to follow-up, the proportion reporting repeated blood pressure measurement, physician consultation, additional diagnostic evaluation, a new diagnosis of hypertension or a change in medication after the baseline screening visit.	1 to 3 months after baseline screening visit

Collaborators and Investigators

• Sponsor: Dr. Josip Benčević General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: antihypertensive medication; blood pressure screening; public health campaign
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: OBSB-BP-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Aggregated study results may be presented in scientific and professional publications. Data will be stored and processed in accordance with the ethics approval, institutional policies and applicable data protection requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No