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

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

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Telehome Monitoring

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Baldwin; Phone Number: 14377 613-696-7000; Email: asbaldwin@ottawaheart.ca
• Study Contact Backup: Name: Evyanne Quirouette; Phone Number: 17596 613-696-7000; Email: ewooding@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • Recruiting
      • The University of Ottawa Heart Institute
      • Contact: Ashley Baldwin; Phone Number: 14377 613-696-7000; Email: asbaldwin@ottawaheart.ca
      • Contact: Evyanne Quirouette; Phone Number: 17596 613-696-7000; Email: ewooding@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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).	Behavioral: Telehome Monitoring; Participants are enrolled into the Telehome Monitoring program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current state of blood pressure control in virtual settings	To document the status of blood pressure control (both systolic and diastolic) in virtual hypertension care settings.	3 months
Blood pressure response	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.	3 months

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Hassan Mir, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 20210851-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This this a pilot study, individual participant results will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No