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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telehome Monitoring
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Ottawa Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2022
Last Updated
September 1, 2023
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05300503
Brief Title
Evaluating the Use of a Remote Telehome Monitoring Hypertension Program for Patients Receiving Virtual Care
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned in a 1:1 fashion to either the control group or intervention group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Telehome Monitoring
Intervention Description
Participants are enrolled into the Telehome Monitoring program
Primary Outcome Measure Information:
Title
Current state of blood pressure control in virtual settings
Description
To document the status of blood pressure control (both systolic and diastolic) in virtual hypertension care settings.
Time Frame
3 months
Title
Blood pressure response
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Baldwin
Phone
613-696-7000
Ext
14377
Email
asbaldwin@ottawaheart.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Evyanne Quirouette
Phone
613-696-7000
Ext
17596
Email
ewooding@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Mir, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Baldwin
Phone
613-696-7000
Ext
14377
Email
asbaldwin@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Evyanne Quirouette
Phone
613-696-7000
Ext
17596
Email
ewooding@ottawaheart.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This this a pilot study, individual participant results will not be shared with other researchers.

Learn more about this trial

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

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