TEC4Home Blood Pressure Randomized Controlled Trial

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06303206
• Other study ID #: H23-00623
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: University of British Columbia
• Contact: Karen Tran, MD
• Phone: (604) 875-5181
• Email: Karen.Tran4[@]vch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 408
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of intervention on other blood pressure measures	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)	6-months and 12-months