HABPY: Home Assessment of Blood Pressure in PregnancY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility: recruitment rate of HBPT program
研究概览
简要总结
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:
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What is the end-user acceptability of a comprehensive HBPT pilot program in BC?
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What are the effects of a comprehensive HBPT pilot program on factors such as:
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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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility: recruitment rate of HBPT program
时间窗: From time of enrolment to 6 weeks post partum
Average number of participants who are screened and eligible who consent to participate in this study per month of recruitment.
Feasibility: retention rate of HBPT program
时间窗: From time of enrolment to 6 weeks post-partum
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.
Safety: Incidence density of study participants with severe hypertension
时间窗: From time of enrolment to 6 weeks post-partum.
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.
Safety: Proportion of participants with severe hypertension.
时间窗: From time of enrolment to 6 weeks post-partum
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.
次要结局
- End-user acceptability of comprehensive HBPT program based on EuroQol 5 Dimension 5 Level(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.(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).(From time of enrolment to end of study period (6 weeks postpartum).)
研究者
Karen Tran
Clinical Assistant Professor, General Internal Medicine
University of British Columbia