Home Assessment of Blood Pressure in PregnancY (HABPY)

HABPY: Home Assessment of Blood Pressure in PregnancY

The goal of this observational study is to evaluate the feasibility and safety of a comprehensive home blood pressure telemonitoring (HBPT) program for pregnant people with hypertensive disorders of pregnancy (HDP).

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertensive Disorder of Pregnancy
• Intervention / Treatment: Other: Home blood pressure telemonitoring program and clinician monitoring

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Karen Tran, MD; Phone Number: (604) 875-5181; Email: Karen.Tran4@vch.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

People who are pregnant between 20+0 weeks and 26+0 weeks diagnosed with a hypertensive disorder of pregnancy (HDP) such as chronic hypertension, gestational hypertension, or transient elevated blood pressure with HDP risk factors.

Description

Inclusion Criteria:

• Adult patients aged ≥ 19 years
• 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:

• Anticipated inpatient admission
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: recruitment rate of HBPT program	Average number of participants who are screened and eligible who consent to participate in this study per month of recruitment.	From time of enrolment to 6 weeks post partum
Feasibility: retention rate of HBPT program	Rate of patients who are consented and enrolled in study and participate for the duration of the study period compared to those who are lost to follow-up or attrite during the study period.	From time of enrolment to 6 weeks post-partum
Safety: Proportion of participants with severe hypertension.	Number of patients who experience severe hypertension (defined as office/obstetrical visits/home systolic blood pressure (SBP) ≥ 160 mm Hg and/or diastolic blood pressure (DBP) ≥ 110 mm Hg) as a proportion of total study population.	From time of enrolment to 6 weeks post-partum
Safety: Incidence density of study participants with severe hypertension	Proportion of new cases of severe hypertension (defined as office/obstetrical visits/home systolic blood pressure (SBP) ≥ 160 mm Hg and/or diastolic blood pressure (DBP) ≥ 110 mm Hg) divided by the total person-time from enrolment to 6 weeks post-partum.	From time of enrolment to 6 weeks post-partum.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-user acceptability of comprehensive HBPT program based on EuroQol 5 Dimension 5 Level	The EuroQol-5D-5L survey is a standardized instrument used to measure health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity, 1 being the least severe and 5 being the most severe. Acceptability based on change in score from enrolment to end of study period.	From time of enrolment to end of study period (6 weeks postpartum).
End-user acceptability of comprehensive HBPT program based on Spielberger State-Trait Anxiety Inventory 6 (STAI-6) questionnaire.	Health-related quality of life will be assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire; Anxiety will be assessed based on Spielberger State-Trait Anxiety Inventory 6 The State-Trait Anxiety Inventory (STAI) survey is a psychological assessment tool used to measure both temporary (state) and long-standing (trait) levels of anxiety in individuals. he State-Trait Anxiety Inventory (STAI) consists of two subscales: the State Anxiety (S-Anxiety) scale and the Trait Anxiety (T-Anxiety) scale, each with 20 items. Minimum value: 20 (for each subscale) Maximum value: 80 (for each subscale) Interpretation of scores: Higher scores indicate higher levels of anxiety, meaning a worse outcome in terms of anxiety levels. Acceptability based on change in score from enrolment to end of study period.	From time of enrolment to end of study period (6 weeks postpartum).
End-user acceptability of comprehensive HBPT program based on Patient Satisfaction Questionnaire Short Form (PSQ-18).	xconcise survey designed to measure patient satisfaction across multiple dimensions of healthcare, including technical quality, interpersonal manner, communication, and financial aspects. Patient Satisfaction Questionnaire Short Form survey designed to measure patient satisfaction across multiple dimensions of healthcare, including technical quality, interpersonal manner, communication, and financial aspects. Acceptability based on change in score from enrolment to end of study period.	From time of enrolment to end of study period (6 weeks postpartum).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome: Maternal and perinatal adverse conditions	maternal outcomes (maternal mortality, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary edema, acute kidney injury, liver capsule hematoma or rupture, placental abruptions, post-partum hemorrhage, raised liver enzymes, low platelets, admission to intensive care unit, intubation and mechanical ventilation) and offspring outcomes (stillbirth, gestational age at delivery, birthweight, small for gestational age, neonatal mortality, neonatal seizures, admission to neonatal unit, and respiratory support)	From time of enrolment to end of study period (6 weeks postpartum).
Exploratory outcome: Efficacy as defined by proportion of blood pressure readings within guideline readings	Proportion of home SBP and DBP under control defined as SBP < 135 mm Hg and DBP < 85 mm Hg as per national guidelines	From time of enrolment to end of study period (6 weeks postpartum).
Exploratory outcome: Efficacy as defined by mean blood pressures	Mean home SBP and DBP under control defined as SBP < 135 mm Hg and DBP < 85 mm Hg as per national guidelines per trimester	2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
Exploratory outcome: Process outcomes	Number of alerts, phone calls, and technical issues between patients to health team	2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
Exploratory outcome: Anti-hypertensive medications changes	Number of changes to anti-hypertensive medications prescribed during the study period.	2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
Exploratory outcome: Type of medications prescribed	Type of anti-hypertensives that prescribed to patients during the study period	2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
Exploratory outcome: Dose of medications prescribed	Dose of anti-hypertensive medications that are prescribed to patients during the study period	2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
Exploratory outcome: Fidelity to interventions	Adherence to HBPT measured by proportion of: completed 7-day home BP series, anti-hypertensive titration instructions followed correctly and number of study visits attended.	2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
Exploratory outcome: Health care utilization	Number of unscheduled prenatal, emergency room or urgent care visits antenatal and post-partum, in person clinical assessments, and tele-health visits	From time of enrolment to end of study period (6 weeks postpartum).

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Fraser Health; Providence Healthcare; Women's Health Research Institute of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Toxemia; Hypertension
• Other Study ID Numbers: H23-03815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No