TEC4Home Blood Pressure Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Hypertension

• Registration Number: NCT06303206
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Start: 2024-06-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 408

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure controlled	12-months	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)

Secondary Outcome Measures

Name	Time	Method
Impact of intervention on other blood pressure measures	6-months and 12-months	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)