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

Hypertension Clinical Trial

— HTMTHM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300503
• Other study ID #: 20210851-01H
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: February 2024

Study information

• Verified date: September 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Ashley Baldwin
• Phone: 613-696-7000
• Email: asbaldwin[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Telehome Monitoring
Participants are enrolled into the Telehome Monitoring program

Locations

Country	Name	City	State
Canada	The University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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