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Telehome Monitoring for High Blood Pressure (HTMTHM Trial)
N/A
Recruiting
Led By Hassan Mir, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
HTMTHM Trial Summary
This trial is testing a program to help people with high blood pressure keep it under better control while receiving care virtually for coronavirus.
Who is the study for?
This trial is for individuals with primary, essential high blood pressure who can speak English or French and have access to a phone and a cellular network at home. It's not for those managed at specialized clinics, planning extensive travel, pregnant women, residents in long-term care facilities, or those with cognitive impairments.Check my eligibility
What is being tested?
The study tests if a special blood pressure cuff and remote monitoring program can help patients manage their high blood pressure better during times when healthcare is mostly virtual due to the COVID-19 pandemic.See study design
What are the potential side effects?
Since this trial involves non-invasive telehome monitoring rather than medication or invasive procedures, there are no direct side effects associated with its use.
HTMTHM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure response
Current state of blood pressure control in virtual settings
HTMTHM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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 II: ControlActive Control1 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 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telehome Monitoring
2016
N/A
~470
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,336 Total Patients Enrolled
Hassan Mir, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
4 Previous Clinical Trials
790 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently being treated for high blood pressure at a special clinic or through a remote monitoring program.You have been diagnosed with high blood pressure.You have a condition that affects your thinking or mental health and would make it hard for you to take part in the study.You need to have access to a 4G cellular network at your home to use the Aetonix aTouchAway platform, even if you don't have your own cellphone.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for participants in this research project?
"The clinical trial is presently recruiting patients, with the original post date being August 4th of 2022 and a recent update on August 11th."
Answered by AI
What is the current participant count for this experiment?
"Affirmative. Records on clinicaltrials.gov demonstrate that this experiment, which was initially posted to the public domain on August 4th 2022, is actively recruiting subjects. As of now, 100 test subjects are required from a single medical facility."
Answered by AI
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