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

NCT ID: NCT05300503

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-04
• Study Completion Date: 2026-01-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 Type: EXPERIMENTAL

Telehome Monitoring

Intervention Type: BEHAVIORAL

Participants are enrolled into the Telehome Monitoring program

Interventions

Telehome Monitoring

Participants are enrolled into the Telehome Monitoring program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Mir, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

The University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20210851-01H

Identifier Type: -

Identifier Source: org_study_id