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Not yet recruiting NCT06303206

TEC4Home Blood Pressure Randomized Controlled Trial

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM).
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Systolic blood pressure controlled [Time frame: 12-months]
Secondary outcome measures (1)
  • Impact of intervention on other blood pressure measures [Time frame: 6-months and 12-months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06303206 · H23-00623

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗