TEC4Home Blood Pressure Randomized Controlled Trial

NCT ID: NCT06303206

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-01-01

Brief Summary

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Karen Tran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Karen Tran, MD

Role: CONTACT

Karen.Tran4@vch.ca

(604) 875-5181

Meagan Mak, BA

Role: CONTACT

meagan.mak@ubc.ca

(604) 822-8359

Other Identifiers

H23-00623

Identifier Type: -

Identifier Source: org_study_id