Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2024-07-31
2026-01-31
Brief Summary
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Participants will receive training on the use of a home BP telemonitor with tele-transmission function for the remainder of their pregnancy and 6 weeks postpartum. Participating obstetric internal medicine (OBIM) clinicians will monitor the transmitted values and adjust anti-hypertensive medications based on the home BP readings.
Our primary goal is to describe the feasibility and safety of a comprehensive HBPT pilot program in British Columbia, Canada (BC).
Secondary research questions will address:
1. What is the end-user acceptability of a comprehensive HBPT pilot program in BC?
2. What are the effects of a comprehensive HBPT pilot program on factors such as:
1\. Maternal and neonatal outcomes 2. Home blood pressure (BP) metrics 3. Process measures 4. Anti-hypertensive medications 5. Fidelity to interventions 6. Health Care utilization
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Home blood pressure telemonitoring program and clinician monitoring
Home Blood Pressure Telemonitoring (HBPT) includes used of an app to collect and transmit blood pressure readings.
Clinician monitoring includes OBIM physicians reviewing transmitted BP data and contacting patients to adjust antihypertensive medication regimens.
Eligibility Criteria
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Inclusion Criteria
* Pregnancy
* Gestational age 20+0 to 36+0 weeks gestational age
* Diagnosed with gestational hypertension (defined as SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg) after 20 weeks gestation OR Chronic hypertension (defined as SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg), present at booking or before 20 weeks gestation, or receiving treatment (including lifestyle measures) prior to pregnancy and/or at time of referral OR Transient elevated office BP reading (defined as one time reading of SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg with risk factors for HDP as per Canadian guidelines).
* Participant is willing and able to give informed consent for participation in the study
* Able and willing to comply with study requirements
* Has smart phone
Exclusion Criteria
* Remaining pregnancy less than 2 weeks duration
* Imminent delivery (within the next 48 hours)
* Non-English speaking or no family members who can help translate
19 Years
FEMALE
No
Sponsors
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Women's Health Research Institute of British Columbia
OTHER
Providence Healthcare
OTHER
Fraser Health
OTHER
University of British Columbia
OTHER
Responsible Party
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Karen Tran
Clinical Assistant Professor, General Internal Medicine
Locations
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University of British Columbia
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Other Identifiers
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H23-03815
Identifier Type: -
Identifier Source: org_study_id
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