TEC4Home Blood Pressure Randomized Controlled Trial

University of British Columbia

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Device: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06303206

H23-00623

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (HBPT) and case management (CM), relative to usual care, for improving blood pressure (BP) control among patients with high blood pressure discharged from the emergency department (ED).

The main question it aims to answer is: Does telemonitoring with case management improve BP control, relative to usual care, for people with high blood pressure discharged from the ED?

Secondary research questions will address:

1. How do these interventions (telemonitoring and case management) improve medication adherence?
2. Do these interventions reduce physician and ED visits?
3. Are these interventions safe?
4. How do these interventions influence patient experience?

Participants in the intervention group will receive training and use of a home BP telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored BP data, and adjust medications. The control group will receive usual care from their primary care physician and will receive the same home BP monitor and hypertension education.

Enrollment: 408 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients aged ≥ 18 years of age
• Elevated triage BP AND increased average BP in three subsequent repeated measurements that are spaced at least 30 minutes after triage (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 100 mm Hg)
• Own a smart phone
• Willing to measure and tele-transmit home BP readings

Exclusion criteria

• Hypertensive emergencies with evidence of end-organ damage, stroke, or acute coronary syndrome
• Pregnant women
• Acute intoxication
• Acute surgical or trauma patients
• Psychiatrically unstable patients
• Advanced cognitive impairment
• Patient requiring admission to hospital
• Inability to use or care for home BP monitor correctly
• From nursing home
• Unstable housing
• Non-English speaking or no family members who can help translate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)

Experimental group

Description:

This group will be asked to follow home BP monitoring as per instructions. Results will be transmitted and telemonitored using an app, where case managers (designated pharmacists) will monitor BP values to provide counselling for medication adherence and behavioural support and review telemonitored BP summaries and adjust BP medications according to protocol. Case management teams will contact participants at baseline and every month until the end of the study, or more frequently if BP is uncontrolled.

Treatment:

Device: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)

Usual Care

No Intervention group

Description:

This group will receive usual care by their primary care provider and provided with hypertension education materials similar to the intervention group. Participants will receive the same home BP monitor to encourage monitoring of home BP based on hypertension guideline recommendations. Home BP readings will tele-transmit via the app for study purposes, but not made available to the case managers or primary care providers, except if necessary for safety reasons, or at the discretion of the data safety monitoring physician.