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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05300503
Acronym
HTN THM
Enrollment
100
Registered
2022-03-29
Start date
2022-08-04
Completion date
2026-01-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Interventions

Participants are enrolled into the Telehome Monitoring program

Sponsors

Ottawa Heart Institute Research Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Participants will be randomly assigned in a 1:1 fashion to either the control group or intervention group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Current state of blood pressure control in virtual settings3 monthsTo document the status of blood pressure control (both systolic and diastolic) in virtual hypertension care settings.
Blood pressure response3 monthsOur 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.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORHassan Mir, MD

Ottawa Heart Institute Research Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026