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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure response

Current state of blood pressure control in virtual settings

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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