Not Yet Recruiting

NCT Number: NCT06303206

TEC4Home 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Systolic blood pressure controlled

Time frame: 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 outcomes

Impact of intervention on other blood pressure measures

Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Tran, MD

CONTACT

[email protected]

(604) 875-5181

Meagan Mak, BA

CONTACT

[email protected]

(604) 822-8359

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Mar 12, 2024
Registry last updated: Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting