Clinical trial NCT05300503: Evaluating the Use of a Remote Telehome Monitoring Hypertension Program for Patients Receiving Virtual Care
Official title: Evaluating the Use of a Remote Telehome Monitoring and Management Hypertension Program for Patients Receiving Virtual Care: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned in a 1:1 fashion to either the control group or intervention group.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Current state of blood pressure control in virtual settings
timeFrame: 3 months
measure: Blood pressure response
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Hassan Mir, MD
role: PRINCIPAL_INVESTIGATOR
References: