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

25 de junio de 2026 actualizado por: Katica Cvitkusic Lukenda, Dr. Josip Benčević General Hospital

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

500

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Katica Cvitkušić Lukenda, MD, PhD
  • Número de teléfono: +38598556576
  • Correo electrónico: kclukenda@gmail.com

Ubicaciones de estudio

    • Brod-Posavina County
      • Slavonski Brod, Brod-Posavina County, Croacia, 35000
        • General Hospital Dr. Josip Bencevic
        • Contacto:
          • Katica Cvitkušić Lukenda, MD, PhD
          • Número de teléfono: +38598556576
          • Correo electrónico: kclukenda@gmail.com
        • Contacto:
        • Investigador principal:
          • Katica Cvitkušić Lukenda, MD, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prevalence of elevated blood pressure among adults attending community-based public health screening campaigns
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of participants with previously known hypertension
Periodo de tiempo: Baseline screening visit
Proportion of participants who self-report a previous diagnosis of arterial hypertension.
Baseline screening visit
Proportion of participants receiving antihypertensive medication
Periodo de tiempo: Baseline screening visit
Proportion of participants who report current use of antihypertensive medication.
Baseline screening visit
Proportion of treated participants with elevated blood pressure at screening
Periodo de tiempo: 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
Periodo de tiempo: 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
Proportion of participants advised to contact a physician
Periodo de tiempo: Baseline screening visit
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
Periodo de tiempo: Baseline screening visit
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
Periodo de tiempo: 1 to 3 months after baseline screening visit
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de julio de 2026

Finalización primaria (Estimado)

15 de julio de 2027

Finalización del estudio (Estimado)

15 de julio de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de junio de 2026

Publicado por primera vez (Actual)

26 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • OBSB-BP-2026-001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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