Performance of the Cloud DX connected HealthKit Pulsewave in home blood
pressure monitoring in a pregnant population: a clinical evaluation and
user experience study
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.