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TEC4Home Blood Pressure Randomized Controlled Trial

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06303206
Enrollment
408
Registered
2024-03-12
Start date
2024-06-01
Completion date
2027-01-01
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DEVICEHome 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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressure controlled12-monthsComparison 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

MeasureTime frameDescription
Impact of intervention on other blood pressure measures6-months and 12-monthsAmbulatory 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)

Contacts

Primary ContactKaren Tran, MD
Karen.Tran4@vch.ca(604) 875-5181
Backup ContactMeagan Mak, BA
meagan.mak@ubc.ca(604) 822-8359

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026