NCT03209024

Smartphone App Assisted Home Blood Pressure Monitoring Amongst Hypertensive Patients in Singapore

App Documentation of Electronic BP Readings in Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Duke-NUS Graduate Medical School · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Background: Hypertension is the leading attributable risk factor for cardiovascular disease and death globally. In diagnosing and monitoring hypertensive patient population, home blood pressure monitoring (HBPM) has been shown to be superior to the office-based blood pressure (BP) measurement as a predictor of cardiovascular disease and total mortality. However, the conventional method of HBPM utilizing handwritten BP logbooks has known shortcomings, mainly attributable to inaccuracy and underreporting of data, as well as the failure to bring the logbooks to the regular outpatient appointments. In recent years, the availability of home BP devices with Bluetooth® technology on the market, the increasingly widespread use of smartphones, and the development of mobile applications (apps) that complement Bluetooth® enabled BP monitors have expanded the potential for an accurate log of BP data to be accessible to clinicians. Our study's primary aim is to compare the level of HBPM recording fidelity using smartphone app versus using a handwritten logbook among the multi-ethnic hypertensive patient population seen in a district polyclinic located in Pasir Ris, Singapore. Patient acceptability of the two recording modalities and the association between the home blood pressure recording fidelity and the patients' socio-demographic background, self-care profile, clinical factors, and level of exposure to technology is also assessed as exploratory aims. Our main hypothesis is that the level of fidelity in HBPM recording, defined as the proportion of scheduled number of home blood pressure readings that is successfully recorded, regimen compliant, and made available at the final follow up visit, would be higher for patients who use a smartphone app versus those who maintain a handwritten logbook. Methods/design: Open, randomized controlled trial of 80 patients seen at Pasir Ris Polyclinic randomized to either intervention or control arm and assessed after a 3-week follow up period Intervention arm: Participants randomized to intervention arm follow a 3-week HBPM regimen and wirelessly record the BP readings onto a smartphone app using Bluetooth® technology. Control arm: Participants randomized to control arm follow a 3-week HBPM regimen (identical to intervention arm) and manually record the BP readings onto a handwritten logbook. Participants: A convenience sample of 80 patients visiting the study polyclinic was obtained during the recruitment period (15 Mar 2017 - 15 June 2017). Outcomes: A trained outcomes assessor will assess each participant's home BP record brought to the final follow up visit at 3 weeks post-randomization. The primary outcome will be HBPM recording fidelity, defined as the proportion of scheduled number of home blood pressure readings that is successfully recorded, regimen compliant, and made available at the final follow up visit. The participants' level of discomfort during the study, their willingness to incorporate into their healthcare management the modality of HBPM to which they were assigned, and their overall impression on their study participation will be assessed by a participant acceptability questionnaire.

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	Handwritten logbook recording of home blood pressure readings	Participants use a handwritten logbook to record the details of their home blood pressure measurements, including systolic blood pressure, diastolic blood pressure, date, and time.
DEVICE	Smartphone assisted wireless recording of home blood pressure readings	Participants use a smartphone app and Bluetooth® technology to wirelessly record the details of their home blood pressure measurements, including systolic blood pressure, diastolic blood pressure, date, and time.

Timeline

• Start date: 2017-03-15
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2017-07-06
• Last updated: 2017-07-06

Locations

1 site across 1 country: Singapore