Validity of 1BPM for Diagnosis of Hypertension

Study Overview
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Brief Summary
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Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. A recent British guideline recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these devices are not available at all health centers and they can only be used by one patient per day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM), to diagnose the hypertension. Participants with suspected hypertension will be recruited from a population of patients seen at three primary health centers in an urban area. According to the sample size estimation, a minimum sample size of 214 participants would be needed for the study. Four diagnostic tests will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be compared to all other monitoring methods using the correlation coefficients and Bland Altman plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and specificity of the methods will also be calculated.

Official Title
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Validity of 1-hour Blood Pressure Monitoring Against the Usual Methods for Diagnosis of Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Diagnostic Test: 1-hour blood pressure monitoring (1BPM)
* Diagnostic Test: 24-hour ambulatory blood pressure monitoring (ABPM)
* Diagnostic Test: Office blood pressure measurement (OBPM)
* Diagnostic Test: Home blood pressure monitoring (HBPM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years To visit routinely in the health centres where the study is carried out Exclusion Criteria: Severe physical or cognitive limitations Atrial fibrillation or other heart rhythm disorders that could interfere with readings Arm Circumference > 42cm Arm with arteriovenous fistula Mental disorders Intolerance to the method of measurement Hospitalization during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood pressure monitoring<br> | Diagnostic Test: 1-hour blood pressure monitoring (1BPM)<br>* This method consists of performing blood pressure measurements programmed at 5-min intervals over 1 hour. Two extra recordings taken at the start and end of this period are discarded. Blood pressure is measured in a quiet room at the same health centre.<br>Diagnostic Test: 24-hour ambulatory blood pressure monitoring (ABPM)<br>* The device is programmed to record the participant's BP every 20 min and 30 min during the day and night, respectively. Participants are advised to carry on with their normal daily activities, avoiding any intense physical exertion, and to remain at rest when their BP is being measured.<br>Diagnostic Test: Office blood pressure measurement (OBPM)<br>* Two readings were made one minute apart with a validated automatic sphygmomanometer in a sitting position after five minutes of rest. The average of two readings is calculated. The procedure is repeated during 3 office visits at least a week apart.<br>Diagnostic Test: Home blood pressure monitoring (HBPM)<br>* For each blood pressure recording, at least two consecutive measurements should be taken, at least one minute apart. Blood pressure should be recorded twice daily, ideally in the morning and evening. Blood pressure recording should continue for at least four consecutive days, ideally seven. The average of the above readings should be calculated, ignoring the first day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-hour blood pressure monitoring | Blood pressure measurements obtained by 1-hour blood pressure monitoring | Assessed at 1 study visit (1 hour) | 
| 24-hour ambulatory blood pressure monitoring | Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring | Assessed at 1 day | 
| Office blood pressure measurement | Blood pressure measurements obtained by office blood pressure measurement | Assessed at 3 study visits in two weeks | 
| Home blood pressure monitoring | Blood pressure measurements obtained by home blood pressure monitoring | Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Blood pressure monitoring