An interventional study of Handwritten logbook recording of home blood pressure readings and Smartphone assisted wireless recording of home blood pressure readings in Hypertension, sponsored by Duke-NUS Graduate Medical School. Status unknown at 1 site in Singapore. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-06.
Sponsored by Duke-NUS Graduate Medical School · Not applicable, Interventional, and Other
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 80 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Exclusion Criteria:
Participants complete a 3-week home blood pressure monitoring regimen using a handwritten logbook to record all blood pressure readings.
Other: Handwritten logbook recording of home blood pressure readings
Participants complete a 3-week home blood pressure monitoring regimen using a smartphone app and Bluetooth® technology to wirelessly record all blood pressure readings.
Device: Smartphone assisted wireless 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.
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.
Home Blood Pressure Recording Fidelity within each study arm
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.
Time frame: Baseline visit to 3 weeks post randomization
The association of participants' age with home blood pressure recording fidelity within each study arm
regression coefficient p-value \< 0.05 is considered to be statistically significant
Time frame: Baseline visit to 3 weeks post randomization
The association of participants' highest level of education with home blood pressure recording fidelity within each study arm
regression coefficient p-value \< 0.05 is considered to be statistically significant
Time frame: Baseline visit to 3 weeks post randomization
The association of participants' years of smartphone use with home blood pressure recording fidelity within each study arm
regression coefficient p-value \< 0.05 is considered to be statistically significant
Time frame: Baseline visit to 3 weeks post randomization
Participant Acceptability of the home blood pressure recording modality within each study arm
A trained outcomes assessor administers the Participant Acceptability Questionnaire to assess 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.
Time frame: Baseline visit to 3 weeks post randomization
Plan to share: No
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Duke-NUS Graduate Medical School