Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting (OMRONHEM-907)
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|ClinicalTrials.gov Identifier: NCT03360669|
Recruitment Status : Completed
First Posted : December 4, 2017
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Sequence: Clinical/Research Other: Sequence: Research/Clinical||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting|
|Actual Study Start Date :||November 27, 2017|
|Actual Primary Completion Date :||March 29, 2018|
|Actual Study Completion Date :||March 29, 2018|
Experimental: Sequence: Clinical/Research
Participants assigned to this arm will have their blood pressure measured in a clinical setting first, and in a research setting second. The sequence randomization corresponds to the intervention. Visits will be at least a day apart but within a two-week period. During the clinical visit, they will have their blood pressure measured with the Omron HEM-907, an automated office blood pressure (AOBP) device. During the research setting, participants will be guided through a series of research-driven steps such as study questionnaires and completion of consent forms. They will have their blood pressure measured in both arms with a mercury sphygmomanometer, and then 3 measurements with a mercury sphygmomanometer. AOBP measurements (Omron HEM-907) will be performed at the end of the visit.
Other: Sequence: Clinical/Research
Participants will be assigned to a sequence of: research visit first/clinical visit second.
Active Comparator: Sequence: Research/Clinical
Participants assigned to this arm will go through the same measurements and procedures exception made of the research-first and clinical-second sequence. The intervention to which they are randomized corresponds to the sequence of the visits.
Other: Sequence: Research/Clinical
Participants will be assigned to a sequence of: clinical visit first/research visit second.
- Mean automated office blood pressure systolic blood pressure estimates [ Time Frame: Up to 2 weeks ]
- Mean automated office blood pressure diastolic blood pressure estimates. [ Time Frame: Up to 2 weeks ]
- Individual unaveraged automated office systolic and diastolic blood pressure measurements (1, 2 and 3) [ Time Frame: Up to 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360669
|Institut de Recherches Cliniques de Montréal|
|Montreal, Quebec, Canada, H2W1R7|