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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209024
Recruitment Status : Unknown
Verified July 2017 by Professor Tazeen Jafar, Duke-NUS Graduate Medical School.
Recruitment status was:  Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
SingHealth Polyclinics
Information provided by (Responsible Party):
Professor Tazeen Jafar, Duke-NUS Graduate Medical School

Brief 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.


Condition or disease Intervention/treatment Phase
Hypertension Other: Handwritten logbook recording of home blood pressure readings Device: Smartphone assisted wireless recording of home blood pressure readings Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: App Documentation of Electronic BP Readings in Hypertension
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : July 31, 2017
Estimated Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control
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 use a handwritten logbook to record the details of their home blood pressure measurements, including systolic blood pressure, diastolic blood pressure, date, and time.

Experimental: Intervention
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 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.




Primary Outcome Measures :
  1. Home Blood Pressure Recording Fidelity within each study arm [ Time Frame: Baseline visit to 3 weeks post randomization ]
    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.


Secondary Outcome Measures :
  1. The association of participants' age with home blood pressure recording fidelity within each study arm [ Time Frame: Baseline visit to 3 weeks post randomization ]
    regression coefficient p-value < 0.05 is considered to be statistically significant

  2. The association of participants' highest level of education with home blood pressure recording fidelity within each study arm [ Time Frame: Baseline visit to 3 weeks post randomization ]
    regression coefficient p-value < 0.05 is considered to be statistically significant

  3. The association of participants' years of smartphone use with home blood pressure recording fidelity within each study arm [ Time Frame: Baseline visit to 3 weeks post randomization ]
    regression coefficient p-value < 0.05 is considered to be statistically significant


Other Outcome Measures:
  1. Participant Acceptability of the home blood pressure recording modality within each study arm [ Time Frame: Baseline visit to 3 weeks post randomization ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209024


Locations
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Singapore
SingHealth Polyclinics - Pasir Ris
Singapore, Singapore, 519457
Sponsors and Collaborators
Duke-NUS Graduate Medical School
SingHealth Polyclinics
Investigators
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Principal Investigator: Tazeen Jafar, MD, MPH Duke-NUS Graduate Medical School
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Tazeen Jafar, Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT03209024    
Other Study ID Numbers: 2017/2014
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Tazeen Jafar, Duke-NUS Graduate Medical School:
hypertension
home blood pressure monitoring
self blood pressure monitoring
telemedicine
health apps
informatics
data collection
personal health records
smartphone
self care
blood pressure monitors
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases