- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07670741
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Katica Cvitkušić Lukenda, MD, PhD
- Numéro de téléphone: +38598556576
- E-mail: kclukenda@gmail.com
Lieux d'étude
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Brod-Posavina County
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Slavonski Brod, Brod-Posavina County, Croatie, 35000
- General Hospital Dr. Josip Bencevic
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Contact:
- Katica Cvitkušić Lukenda, MD, PhD
- Numéro de téléphone: +38598556576
- E-mail: kclukenda@gmail.com
-
Contact:
- E-mail: kclukenda@gmail.com
-
Chercheur principal:
- Katica Cvitkušić Lukenda, MD, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prevalence of elevated blood pressure among adults attending community-based public health screening campaigns
Délai: Baseline screening visit
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of participants with previously known hypertension
Délai: Baseline screening visit
|
Proportion of participants who self-report a previous diagnosis of arterial hypertension.
|
Baseline screening visit
|
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Proportion of participants receiving antihypertensive medication
Délai: Baseline screening visit
|
Proportion of participants who report current use of antihypertensive medication.
|
Baseline screening visit
|
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Proportion of treated participants with elevated blood pressure at screening
Délai: Baseline screening visit
|
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
Délai: Baseline screening visit
|
Proportion of participants reporting cardiovascular risk factors, including smoking, diabetes mellitus, dyslipidemia, obesity, chronic kidney disease and previous cardiovascular disease.
|
Baseline screening visit
|
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Proportion of participants advised to contact a physician
Délai: Baseline screening visit
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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.
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Baseline screening visit
|
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Distribution of antihypertensive medication classes
Délai: Baseline screening visit
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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.
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Baseline screening visit
|
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Follow-up outcomes among participants consenting to short-term follow-up
Délai: 1 to 3 months after baseline screening visit
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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
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OBSB-BP-2026-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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