Home Assessment of Blood Pressure in PregnancY
NCT Number: NCT06491199
Acronym: HABPY
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypertensive Disorder of Pregnancy
Interventions: OTHER: Home blood pressure telemonitoring program and clinician monitoring
Sponsor: University of British Columbia
Collaborators: Women's Health Research Institute of British Columbia|Providence Healthcare|Fraser Health
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-01
Locations: University of British Columbia, Vancouver, British Columbia, V5Z1M9, Canada

Summary:
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

Primary Outcome Measures: 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: 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: 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).