TEC4Home Blood Pressure Randomized Controlled Trial

Telehealth for Emergency-Community Continuity of Care Connectivity Via Home Telemonitoring for Blood Pressure Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Device: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)

• Study Type: Interventional
• Enrollment (Estimated): 408
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Tran, MD; Phone Number: (604) 875-5181; Email: Karen.Tran4@vch.ca
• Study Contact Backup: Name: Meagan Mak, BA; Phone Number: (604) 822-8359; Email: meagan.mak@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM); 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.	Device: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM); Home Blood Pressure Telemonitoring (HBPT) includes used of an app to collect and transmit blood pressure readings. Case Management (CM) includes pharmacists reviewing BP data and providing counselling to participants based on their BP values.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure controlled	Comparison of proportion of participants in intervention group versus control group achieving 24h daytime SBP control (< 135 mm Hg or < 130 mm Hg if diabetic)	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of intervention on other blood pressure measures	Ambulatory BP 24h average SBP 24h average DBP 24h daytime average SBP 24h daytime DBP 24h nighttime SBP 24h nighttime DBP Home BP Home SBP average Home DBP average Proportion achieving 24h daytime DBP control (< 85 mm Hg or < 80 mm Hg if diabetic)	6-months and 12-months

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: H23-00623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No