Abstract:
Objective: Clinical evaluation and user experience of the Cloud
DX connected HealthKit Pulsewave wrist cuff blood pressure monitor
(CDXP) for home blood pressure monitoring during pregnancy (HBPM).
Methods: In the first phase, an adjusted version of the
European Society of Hypertension International Protocol Revision 2010
(ESH-IP 2010) was used to compare the CDXP and Omron M6 Comfort to the
aneroid manometer. In the second phase, blood pressure measurement at
home was compared to standard office blood pressure measurement (OBPM).
Patients filled out a questionnaire regarding user experience.
Results: In 34 pregnant women the blood pressure measured by
the aneroid manometer did not differ from the CDXP (systolic blood
pressure (SBP) difference: -0.7±6.5 mmHg (p=0.38), diastolic blood
pressure (DBP) difference: 0.4±5.7 mmHg (p=0.55)), while the aneroid
manometer measured SBP slightly higher (1.5±5.8 mmHg (p=0.04)) and DBP
slightly lower (-2.8±5.8 mmHg (p<0.01)) as compared to the
Omron M6 Comfort. In 32 patients the SBP of the office hospital
measurement was significantly higher, while DBP was comparable.
The mean user experience score for the CDXP was 85%, corresponding with
an ‘excellent’ evaluation. Of all patients, 97% reported they liked the
idea of home monitoring and would like to use it in the future.
Conclusion: The CDXP is as reliable as standard office blood
pressure monitors during pregnancy and gives a better representation of
the blood pressure than standard hospital measurement. Pregnant women
are positive and confident about HBPM and find the CDXP easy to use.