HypertensionADELPHYNCT03209024
Smartphone App Assisted Home Blood Pressure Monitoring Amongst Hypertensive Patients in Singapore
A study testing Handwritten logbook recording of home blood pressure readings and Smartphone assisted wireless recording of home blood pressure readings in people with Hypertension, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Handwritten logbook recording of home blood pressure readings and Smartphone assisted wireless recording of home blood pressure readings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Mar 2017to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- Maximal arm circumference exceeding BP cuff size
- Anticipation of extensive travel overseas during study period
- Occupation requires night shift
- Participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: App Documentation of Electronic BP Readings in Hypertension
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
Read more
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
- Being tested
- Handwritten logbook recording of home blood pressure readings, Smartphone assisted wireless recording of home blood pressure readings
- Keywords
- hypertension, home blood pressure monitoring, self blood pressure monitoring, telemedicine, health apps, informatics, data collection, personal health records, smartphone, self care, blood pressure monitors
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handwritten logbook recording of home blood pressure readingsOther
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.
Smartphone assisted wireless recording of home blood pressure readingsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Participants complete a 3-week home blood pressure monitoring regimen using a handwritten logbook to record all blood pressure readings. Receives: Other: Handwritten logbook recording of home blood pressure readings |
| Intervention | Experimental | Participants complete a 3-week home blood pressure monitoring regimen using a smartphone app and Bluetooth® technology to wirelessly record all blood pressure readings. Receives: Device: Smartphone assisted wireless recording of home blood pressure readings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline visit to 3 weeks post randomization
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Baseline visit to 3 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start15 Mar 2017
- Primary completion31 Jul 2017 (estimated)
- Study completion31 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- SingHealth Polyclinics
- Responsible party
- Principal investigator, Professor Tazeen Jafar, Duke-NUS Graduate Medical School
- Investigators
- Tazeen Jafar, MD, MPH, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209024
- Sponsor's protocol ID
- 2017/2014
- Acronym
- ADELPHY
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18456100Niiranen TJ, Hanninen 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.
PubMed 20385970Mengden 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. doi: 10.1016/s0895-7061(98)00241-6.
PubMed 9880121Stergiou 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. doi: 10.1016/s0895-7061(01)02324-x.
PubMed 11863243Ohkubo 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. doi: 10.1097/00004872-200406000-00009.
PubMed 15167443Chatellier G, Day M, Bobrie G, Menard J. Feasibility study of N-of-1 trials with blood pressure self-monitoring in hypertension. Hypertension. 1995 Feb;25(2):294-301. doi: 10.1161/01.hyp.25.2.294.
PubMed 7843782Tamaki 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. doi: 10.2169/internalmedicine.47.0710. Epub 2008 Sep 16.
PubMed 18797113Han HR, Lee H, Commodore-Mensah Y, Kim M. Development and validation of the Hypertension Self-care Profile: a practical tool to measure hypertension self-care. J Cardiovasc Nurs. 2014 May-Jun;29(3):E11-20. doi: 10.1097/JCN.0b013e3182a3fd46.
PubMed 24088621Wu 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.
PubMed 27512876Tinetti 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.
PubMed 24567036Moon EW, Tan NC, Allen JC, Jafar TH. The Use of Wireless, Smartphone App-Assisted Home Blood Pressure Monitoring Among Hypertensive Patients in Singapore: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 May 28;7(5):e13153. doi: 10.2196/13153.
PubMed 30905872
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App Documentation of Electronic BP Readings in Hypertension
- ClinicalTrials.gov ID
- NCT03209024
- Acronym / sponsor ID
- ADELPHY / 2017/2014
- Conditions
- Hypertension
- Keywords
- hypertension, home blood pressure monitoring, self blood pressure monitoring, telemedicine, health apps, informatics, data collection, personal health records
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- SingHealth Polyclinics
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 31 Jul 2017 (estimated)
- Study completion
- 31 Jul 2017 (estimated)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Handwritten logbook recording of home blood pressure readingsParticipants complete a 3-week home blood pressure monitoring regimen using a handwritten logbook to record all blood pressure readings. |
| Intervention | Experimental | Device: Smartphone assisted wireless recording of home blood pressure readingsParticipants complete a 3-week home blood pressure monitoring regimen using a smartphone app and Bluetooth® technology to wirelessly record all blood pressure readings. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Known cardiac arrhythmia
- Known end stage renal disease
- Known cancer patient
- Known history of stroke
- Known history of myocardial infarct
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handwritten logbook recording of home blood pressure readingsParticipants use a handwritten logbook to record the details of their home blood pressure measurements, including systolic blood pressure, diastolic blood pressure, date, and time. | Other | Control |
| Smartphone assisted wireless recording of home blood pressure readingsParticipants 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. | Device | Intervention |
Primary outcome
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.
3 secondary outcomes
The association of participants' age with home blood pressure recording fidelity within each study arm
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
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
Time frame: Baseline visit to 3 weeks post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Background: PubMed 18456100Lawes 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.
- Background: PubMed 20385970Niiranen TJ, Hanninen 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.
- Background: PubMed 9880121Mengden 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. doi: 10.1016/s0895-7061(98)00241-6.
- Background: PubMed 11863243Stergiou 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. doi: 10.1016/s0895-7061(01)02324-x.
- Background: PubMed 15167443Ohkubo 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. doi: 10.1097/00004872-200406000-00009.
- Background: PubMed 7843782Chatellier G, Day M, Bobrie G, Menard J. Feasibility study of N-of-1 trials with blood pressure self-monitoring in hypertension. Hypertension. 1995 Feb;25(2):294-301. doi: 10.1161/01.hyp.25.2.294.
- Background: PubMed 18797113Tamaki 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. doi: 10.2169/internalmedicine.47.0710. Epub 2008 Sep 16.
- Background: PubMed 24088621Han HR, Lee H, Commodore-Mensah Y, Kim M. Development and validation of the Hypertension Self-care Profile: a practical tool to measure hypertension self-care. J Cardiovasc Nurs. 2014 May-Jun;29(3):E11-20. doi: 10.1097/JCN.0b013e3182a3fd46.
- Background: PubMed 27512876Wu 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.
- Background: PubMed 24567036Tinetti 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.
- Derived from this study: PubMed 30905872Moon EW, Tan NC, Allen JC, Jafar TH. The Use of Wireless, Smartphone App-Assisted Home Blood Pressure Monitoring Among Hypertensive Patients in Singapore: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 May 28;7(5):e13153. doi: 10.2196/13153.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tazeen Jafar, MD, MPH principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handwritten logbook recording of home blood pressure readings and Smartphone assisted wireless recording of home blood pressure readings in people with Hypertension, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home Blood Pressure Recording Fidelity within each study arm (time frame: Baseline visit to 3 weeks post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209024, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.