Hypertension
Conditions
Keywords
Hypertension, Blood pressure monitoring
Brief summary
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.
Interventions
DIAGNOSTIC_TEST24-hour ambulatory blood pressure monitoring (ABPM)
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.
DIAGNOSTIC_TEST1-hour blood pressure monitoring (1BPM)
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.
DIAGNOSTIC_TESTOffice blood pressure measurement (OBPM)
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.
DIAGNOSTIC_TESTHome blood pressure monitoring (HBPM)
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.
Sponsors
Instituto de Salud Carlos III
Consorci d'Atenció Primària de Salut de l'Eixample
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-hour blood pressure monitoring | Assessed at 1 study visit (1 hour) | Blood pressure measurements obtained by 1-hour blood pressure monitoring |
| 24-hour ambulatory blood pressure monitoring | Assessed at 1 day | Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring |
| Office blood pressure measurement | Assessed at 3 study visits in two weeks | Blood pressure measurements obtained by office blood pressure measurement |
| Home blood pressure monitoring | Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven | Blood pressure measurements obtained by home blood pressure monitoring |
Countries
Spain
Outcome results
None listed