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 Type
OBSERVATIONAL
Enrollment
100
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.
University of British Columbia
Vancouver, British Columbia, Canada
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 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.
Time frame: 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.
Time frame: 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.
Time frame: From time of enrolment to 6 weeks post-partum.
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).
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).
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).
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