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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Katica Cvitkušić Lukenda, MD, PhD
- 電話番号:+38598556576
- メール:kclukenda@gmail.com
研究場所
-
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Brod-Posavina County
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Slavonski Brod、Brod-Posavina County、クロアチア、35000
- General Hospital Dr. Josip Bencevic
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コンタクト:
- Katica Cvitkušić Lukenda, MD, PhD
- 電話番号:+38598556576
- メール:kclukenda@gmail.com
-
コンタクト:
-
主任研究者:
- Katica Cvitkušić Lukenda, MD, PhD
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
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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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Prevalence of elevated blood pressure among adults attending community-based public health screening campaigns
時間枠:Baseline screening visit
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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.
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Baseline screening visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of participants with previously known hypertension
時間枠:Baseline screening visit
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Proportion of participants who self-report a previous diagnosis of arterial hypertension.
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Baseline screening visit
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Proportion of participants receiving antihypertensive medication
時間枠:Baseline screening visit
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Proportion of participants who report current use of antihypertensive medication.
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Baseline screening visit
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Proportion of treated participants with elevated blood pressure at screening
時間枠:Baseline screening visit
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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.
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Baseline screening visit
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Prevalence of cardiovascular risk factors
時間枠:Baseline screening visit
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Proportion of participants reporting cardiovascular risk factors, including smoking, diabetes mellitus, dyslipidemia, obesity, chronic kidney disease and previous cardiovascular disease.
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Baseline screening visit
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Proportion of participants advised to contact a physician
時間枠: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
時間枠: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
時間枠: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.
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1 to 3 months after baseline screening visit
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- OBSB-BP-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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