TEC4Home Blood Pressure Randomized Controlled Trial
- Conditions
- Hypertension
- Interventions
- Device: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 408
- 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
- 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
- Arm && Interventions
Group Intervention Description Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) 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.
- 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)