Home Assessment of Blood Pressure in PregnancY
ConditionHypertensive Disorder of Pregnancy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorUniversity of British Columbia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Home blood pressure telemonitoring program and clinician monitoring
Other interventionHome 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From time of enrolment to 6 weeks post partum2
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.
Time frame
From time of enrolment to 6 weeks post-partum3
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.
Time frame
From time of enrolment to 6 weeks post-partum4
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.
Time frame
From time of enrolment to 6 weeks post-partum.Secondary outcomes
1
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.
Time frame
From time of enrolment to end of study period (6 weeks postpartum).2
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.
Time frame
From time of enrolment to end of study period (6 weeks postpartum).3
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.
Time frame
From time of enrolment to end of study period (6 weeks postpartum).Other outcomes
1
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)
Time frame
From time of enrolment to end of study period (6 weeks postpartum).2
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
Time frame
From time of enrolment to end of study period (6 weeks postpartum).3
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
Time frame
2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)4
Exploratory outcome: Process outcomes
Number of alerts, phone calls, and technical issues between patients to health team
Time frame
2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Women's Health Research Institute of British Columbia
Collaborator
Providence Healthcare
Collaborator
Fraser Health
Collaborator
Source ClinicalTrials.gov
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