Clinical trial NCT06491199: Home Assessment of Blood Pressure in PregnancY
Official title: HABPY: Home Assessment of Blood Pressure in PregnancY
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertensive Disorder of Pregnancy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Women's Health Research Institute of British Columbia
name: Providence Healthcare
name: Fraser Health
First posted: 2024-07-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: recruitment rate of HBPT program
timeFrame: From time of enrolment to 6 weeks post partum
measure: Feasibility: retention rate of HBPT program
timeFrame: From time of enrolment to 6 weeks post-partum
measure: Safety: Proportion of participants with severe hypertension.
timeFrame: From time of enrolment to 6 weeks post-partum
measure: Safety: Incidence density of study participants with severe hypertension
timeFrame: From time of enrolment to 6 weeks post-partum.
Secondary outcomes:
measure: End-user acceptability of comprehensive HBPT program based on EuroQol 5 Dimension 5 Level
timeFrame: From time of enrolment to end of study period (6 weeks postpartum).
measure: End-user acceptability of comprehensive HBPT program based on Spielberger State-Trait Anxiety Inventory 6 (STAI-6) questionnaire.
timeFrame: From time of enrolment to end of study period (6 weeks postpartum).
measure: End-user acceptability of comprehensive HBPT program based on Patient Satisfaction Questionnaire Short Form (PSQ-18).
timeFrame: From time of enrolment to end of study period (6 weeks postpartum).
Other outcomes:
measure: Exploratory outcome: Maternal and perinatal adverse conditions
timeFrame: From time of enrolment to end of study period (6 weeks postpartum).
measure: Exploratory outcome: Efficacy as defined by proportion of blood pressure readings within guideline readings
timeFrame: From time of enrolment to end of study period (6 weeks postpartum).
measure: Exploratory outcome: Efficacy as defined by mean blood pressures
timeFrame: 2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
measure: Exploratory outcome: Process outcomes
timeFrame: 2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
measure: Exploratory outcome: Anti-hypertensive medications changes
timeFrame: 2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
measure: Exploratory outcome: Type of medications prescribed
timeFrame: 2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
measure: Exploratory outcome: Dose of medications prescribed
timeFrame: 2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
measure: Exploratory outcome: Fidelity to interventions
timeFrame: 2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)
measure: Exploratory outcome: Health care utilization
timeFrame: From time of enrolment to end of study period (6 weeks postpartum).
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
References: