HypertensionNCT06303206
TEC4Home Blood Pressure Randomized Controlled Trial
A study testing Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) in people with Hypertension, run by University of British Columbia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home Telemonitoring for 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?
Read more
Secondary research questions will address:
- How do these interventions (telemonitoring and case management) improve medication adherence?
- Do these interventions reduce physician and ED visits?
- Are these interventions safe?
- 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.
- Conditions
- Hypertension
- Being tested
- Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) | Experimental | 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. Receives: Device: Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) |
| Usual Care | No intervention | This group will receive usual care by their primary care provider and provided with hypertension education materials similar to the intervention group. Participants will receive the same home BP monitor to encourage monitoring of home BP based on hypertension guideline recommendations. Home BP readings will tele-transmit via the app for study purposes, but not made available to the case managers or primary care providers, except if necessary for safety reasons, or at the discretion of the data safety monitoring physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12-months
Secondary outcomes (1)
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)
Measured: 6-months and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Tran, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303206
- Sponsor's protocol ID
- H23-00623
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth for Emergency-Community Continuity of Care Connectivity Via Home Telemonitoring for Blood Pressure Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06303206
- Acronym / sponsor ID
- H23-00623
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do these interventions (telemonitoring and case management) improve medication adherence?
- Do these interventions reduce physician and ED visits?
- Are these interventions safe?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) | Experimental | Device: 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. |
| Usual Care | No intervention | –This group will receive usual care by their primary care provider and provided with hypertension education materials similar to the intervention group. Participants will receive the same home BP monitor to encourage monitoring of home BP based on hypertension guideline recommendations. Home BP readings will tele-transmit via the app for study purposes, but not made available to the case managers or primary care providers, except if necessary for safety reasons, or at the discretion of the data safety monitoring physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) |
Primary outcome
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)
1 secondary outcome
Impact of intervention on other blood pressure measures
Time frame: 6-months and 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) in people with Hypertension, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Tran, MD ((604) 875-5181, Karen.Tran4@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure controlled (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.