Evaluating the Use of a Remote Telehome Monitoring Hypertension Program for Patients Receiving Virtual Care

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have a diagnosis of primary, essential HTN (SBP>140/90mmHg or >130/80mmHg for diabetes)
Have access to a phone (can be a landline)
Have access to cellular (4G) network at their primary residence (they do not need to physically own a cellular phone but the need to be able to confirm their residence has 4G network access in order to connect the Aetonix aTouchAway platform to the network)
Speak English or French

Exclusion criteria

Patients who have been referred or who are actively managed at a specialized HTN clinic or other Telehome monitoring program
Women who are pregnant, breastfeeding or planning to become pregnant
Patients who are institutionalized at a retirement home, nursing home or long-term care facility
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)
Patients who are cognitively impaired or experiencing acute psychiatric illness that would alter their ability to participate

Treatment and study plan

Telehome Monitoring

Behavioral

Participants are enrolled into the Telehome Monitoring program

Primary outcomes

Current state of blood pressure control in virtual settings

Time frame: 3 months

To document the status of blood pressure control (both systolic and diastolic) in virtual hypertension care settings.
Blood pressure response

Time frame: 3 months

Our primary outcome, which is the 24-hour ABPM, will be used to measure BP response in the control & intervention group at baseline & after 3-months of the intervention. We will repeat the 24-hour ABPM at 6-months follow up (3-months after completion of the intervention) to assess if there is maintenance of the intervention effects over time. Both systolic and diastolic measurements will be assessed.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

Evaluating the Use of a Remote Telehome Monitoring and Management Hypertension Program for Patients Receiving Virtual Care: A Pilot Randomized Controlled Trial

Acronym: HTN THM

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Mar 29, 2022
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed