TEC4Home Blood Pressure Randomized Controlled Trial

NCT06303206 | Not Yet Recruiting DMC

• 1 other identifier: H23-00623
• Study Type: interventional
• Target: 408
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Impact of intervention on other blood pressure measures

  6-months and 12-months

Study Arms (2)

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

EXPERIMENTAL

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)

Usual Care

NO INTERVENTION

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.

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Karen Tran, MD

CONTACT

(604) 875-5181; Karen.Tran4@vch.ca

Meagan Mak, BA

CONTACT

(604) 822-8359; meagan.mak@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share