100 Participants Needed

Telehome Monitoring for High Blood Pressure

(HTMTHM Trial)

AB
EQ
Overseen ByEvyanne Quirouette
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

High blood pressure or hypertension (HTN) is very common and can lead to serious health issues and even death. Medications and lifestyle changes can be used to treat HTN. During the Coronavirus Disease-19 (COVID-19) pandemic, a lot of the care provided by doctors has become virtual, meaning that patients can be assessed by a doctor over the phone or video call without needing to go to a clinic or hospital. Although this is convenient, a lot of people cannot get their blood pressure (BP) checked in a reliable way when they are at home. As a result, it is possible that their BPs are too high and that they are not getting the right medications or the right doses of medications to treat this. The Investigators are performing this study to see how patients are managing to check their BP's at home, during this time when a lot of the care is virtual. The Investigative team understands that many patients diagnosed with HTN don't have a home BP cuff, or might not know how to properly use it, or might not share the results with their doctors. In people who have high BP, we want to see if a special BP cuff and special monitoring program can help to get their BP's under better control, and to prevent negative effects related to HTN.

Is telehome monitoring for high blood pressure safe?

Research shows that remote blood pressure monitoring, including telehome methods, is generally safe for people. A study found that remote monitoring can be done effectively without face-to-face contact, and the main safety concern was related to cleaning equipment during the COVID-19 pandemic, not the remote monitoring itself.123

How is the Telehome Monitoring treatment for high blood pressure different from other treatments?

Telehome Monitoring is unique because it allows patients to monitor their blood pressure at home and send the data remotely to healthcare providers. This approach enables more frequent and accurate tracking of blood pressure, leading to better management and timely medical interventions compared to traditional in-office visits.45678

Who Is on the Research Team?

HM

Hassan Mir, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with primary, essential high blood pressure who can speak English or French and have access to a phone and a cellular network at home. It's not for those managed at specialized clinics, planning extensive travel, pregnant women, residents in long-term care facilities, or those with cognitive impairments.

Inclusion Criteria

Have access to a phone (can be a landline)
You have been diagnosed with high blood pressure.
You need to have access to a 4G cellular network at your home to use the Aetonix aTouchAway platform, even if you don't have your own cellphone.

Exclusion Criteria

You are currently being treated for high blood pressure at a special clinic or through a remote monitoring program.
Patients who plan on travelling out of the country for more than 2 weeks at any point during the intervention phase of the study (first 3 months)
Women who are pregnant, breastfeeding or planning to become pregnant
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a home monitoring device for blood pressure management and are monitored by a telehome nursing team. Medication titration occurs every 2 weeks if needed.

3 months
Daily virtual monitoring

Control

Participants continue usual activities, receive educational materials, and track blood pressure at home.

3 months
Daily self-monitoring

Follow-up

Participants are monitored for maintenance of blood pressure control effects after the intervention.

3 months
1 visit (virtual) for 24-hour ABPM

What Are the Treatments Tested in This Trial?

Interventions

  • Telehome Monitoring
Trial Overview The study tests if a special blood pressure cuff and remote monitoring program can help patients manage their high blood pressure better during times when healthcare is mostly virtual due to the COVID-19 pandemic.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants will be asked to continue their usual day to day activities and take their current medications as directed. They will be sent a link by email or through MyChart to the educational session described above in the control group section. They will receive an Aetonix aTouchAway platform monitor, which is a disease specific home monitoring device to take home for 3 month intervention period. The device will prompt the participant to check their blood pressure on a daily basis and will send all readings to the UOHI Telehome monitoring program. The telehome monitoring nursing team will monitor the readings for each participant. For hypertensive patients who are not at target with their BP, the telehome monitoring nurse will titrate medications based on an advanced medical directive every 2 weeks. Patients will be provided instructions of when they should seek medical attention (clinical symptoms or SBP \<100 or SBP \>160).
Group II: ControlActive Control1 Intervention
Participants will be asked to continue their usual day to day activities and take their current medications as directed. They will be sent a link by email or through MyChart to the standard video \& education session on managing hypertension. They will watch the video at home on their own time. Participants will use a home blood pressure monitor to track their blood pressure (those without a blood pressure cuff will be provided one) for the 3-month intervention period. Patients will be provided instructions of when they should seek medical attention (clinical symptoms or SBP \<100 or SBP \>160). They will be encouraged to track their blood pressure daily and any symptoms they may be feeling.

Telehome Monitoring is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Telehome Monitoring for:
  • Hypertension management
  • Chronic disease management
🇨🇦
Approved in Canada as Remote Patient Monitoring for:
  • Hypertension management
  • Cardiovascular care
🇪🇺
Approved in European Union as Telehealth Monitoring for:
  • Hypertension management
  • Chronic disease management
  • Cardiovascular care

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Published Research Related to This Trial

Home blood pressure monitoring (HBPM) is an effective self-monitoring tool for managing hypertension, leading to better blood pressure control and helping to identify conditions like white-coat hypertension, as supported by a growing body of evidence.
New HBPM technology features a longer inflatable cuff that improves accuracy by allowing for better placement on the arm, addressing the common issue of inaccurate readings in traditional monitors.
Home Blood Pressure Monitoring.George, J., MacDonald, T.[2022]
Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.
While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.
Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies.Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]
Remote ambulatory blood pressure monitoring (ABPM) can be safely and effectively conducted without face-to-face contact, as demonstrated by a study involving 65 participants, where 88% successfully completed the monitoring.
The study found no significant difference in measurement success rates between remote (88%) and face-to-face (89%) ABPM, indicating that remote methods can provide comparable results in hypertension management during the COVID-19 pandemic.
Ambulatory blood pressure monitoring using telemedicine: proof-of-concept cohort and failure modes and effects analyses.Armitage, LC., Lawson, BK., Roman, C., et al.[2022]

Citations

Home Blood Pressure Monitoring. [2022]
Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]
Ambulatory blood pressure monitoring using telemedicine: proof-of-concept cohort and failure modes and effects analyses. [2022]
Is remote blood pressure monitoring and management a better approach for patients with hypertension? A narrative review. [2023]
Home blood pressure measurement and digital health: communication technologies create a new context. [2019]
Home blood pressure telemonitoring in the 21st century. [2022]
A Universal Noninvasive Continuous Blood Pressure Measurement System for Remote Healthcare Monitoring. [2019]
E-Health in Hypertension Management: an Insight into the Current and Future Role of Blood Pressure Telemonitoring. [2020]
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