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

Hypertension Clinical Trial

— ADELPHY  

Official title:

App Documentation of Electronic BP Readings in Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03209024
• Other study ID #: 2017/2014
• Status: Active, not recruiting
• Phase: N/A
• First received: July 3, 2017
• Last updated: July 3, 2017
• Start date: March 15, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: July 2017
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Singaporean citizen or permanent resident

• Able to communicate in English

• Diagnosis of essential hypertension and on at least one antihypertensive medical therapy

• Between 40-70 years of age

• Owns a smartphone compatible with the study

• Has been visiting the study polyclinic for at least 1 year

Exclusion Criteria:

• Known cardiac arrhythmia

• Known end stage renal disease

• Known cancer patient

• Known history of stroke

• Known history of myocardial infarct

• Physical or mental disability that would prevent one's own measurement of home BP (e.g. visual impairment, dementia)

• Maximal arm circumference exceeding BP cuff size

• Anticipation of extensive travel overseas during study period

• Occupation requires night shift

• Participating in other clinical trials

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Singapore	SingHealth Polyclinics - Pasir Ris	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	SingHealth Polyclinics

Country where clinical trial is conducted

Singapore, 

References & Publications (10)

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Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure-related disease, 2001. Lancet. 2008 May 3;371(9623):1513-8. doi: 10.1016/S0140-6736(08)60655-8. Review. — View Citation

Mengden T, Hernandez Medina RM, Beltran B, Alvarez E, Kraft K, Vetter H. Reliability of reporting self-measured blood pressure values by hypertensive patients. Am J Hypertens. 1998 Dec;11(12):1413-7. — View Citation

Niiranen TJ, Hänninen MR, Johansson J, Reunanen A, Jula AM. Home-measured blood pressure is a stronger predictor of cardiovascular risk than office blood pressure: the Finn-Home study. Hypertension. 2010 Jun;55(6):1346-51. doi: 10.1161/HYPERTENSIONAHA.109.149336. Epub 2010 Apr 12. — View Citation

Ohkubo T, Asayama K, Kikuya M, Metoki H, Hoshi H, Hashimoto J, Totsune K, Satoh H, Imai Y; Ohasama Study. How many times should blood pressure be measured at home for better prediction of stroke risk? Ten-year follow-up results from the Ohasama study. J Hypertens. 2004 Jun;22(6):1099-104. — View Citation

Stergiou GS, Baibas NM, Gantzarou AP, Skeva II, Kalkana CB, Roussias LG, Mountokalakis TD. Reproducibility of home, ambulatory, and clinic blood pressure: implications for the design of trials for the assessment of antihypertensive drug efficacy. Am J Hypertens. 2002 Feb;15(2 Pt 1):101-4. — View Citation

Tamaki S, Nakamura Y, Teramura M, Sakai H, Takayama T, Okabayashi T, Kawashima T, Horie M. The factors contributing to whether or not hypertensive patients bring their home blood pressure record to the outpatient clinic. Intern Med. 2008;47(18):1561-5. Epub 2008 Sep 16. — View Citation

Tinetti ME, Han L, Lee DS, McAvay GJ, Peduzzi P, Gross CP, Zhou B, Lin H. Antihypertensive medications and serious fall injuries in a nationally representative sample of older adults. JAMA Intern Med. 2014 Apr;174(4):588-95. doi: 10.1001/jamainternmed.2013.14764. — View Citation

Wu H, Wang B, Zhu X, Chu G, Zhang Z. A new automatic blood pressure kit auscultates for accurate reading with a smartphone: A diagnostic accuracy study. Medicine (Baltimore). 2016 Aug;95(32):e4538. doi: 10.1097/MD.0000000000004538. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline visit to 3 weeks post randomization
Primary	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.	Baseline visit to 3 weeks post randomization
Secondary	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	Baseline visit to 3 weeks post randomization
Secondary	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	Baseline visit to 3 weeks post randomization
Secondary	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	Baseline visit to 3 weeks post randomization

External Links

•   Ministry of Health. National Health Survey 2010. Singapore Epidemiology and Disease Control Division, Singapore, 2010.
•   Q. S. Sng, Primary Care Survey 2010 Profile of Primary Care Patients, Ministry of Health Singapore, 2011.