HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Diastolic Blood Pressure
研究概览
简要总结
Postpartum remote blood pressure monitoring programs for patients with hypertensive disorders of pregnancy (HDP) are becoming part of standard postpartum management. Existing programs range in duration from 2 to 6 weeks but there has not been any evaluation as to what program duration is optimal. The primary objective of this study is to evaluate the impact of program duration on clinical outcomes for patients participating in a single institution's postpartum remote blood pressure monitoring program for patients with HDP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Discharged after delivery at University of Minnesota Medical Center
- •Enrolled into the HOPE-BP Program
排除标准
- •Ongoing antihypertensive medication use at 2 weeks (time of randomization)
- •Have a medical comorbidity that would not be clinically appropriate to randomize
- •Patients opted out of clinical research
研究组 & 干预措施
2-Week Arm
Participants randomized into the 2 week arm will be immediately unenrolled from the postpartum remote blood pressure monitoring program and resume standard postpartum care
干预措施: 2-Week Home Monitoring (Diagnostic Test)
6-Week Arm
Patients randomized into the 6 week arm will continue and complete the program in its entirety per current SOC (4 additional weeks)
干预措施: 6-Week Home Monitoring (Diagnostic Test)
结局指标
主要结局
Diastolic Blood Pressure
时间窗: Week 6
The primary outcome will be the patient's diastolic blood pressure (DBP) at their 6-week postpartum visit.
次要结局
- Systolic Blood Pressure at 6 weeks post-partum(Week 6)
- 6-Week Post-partum Follow-up Rates(Week 6)
- Unscheduled OB visit, triage visit, ED visit, or readmission rates(Week 6)
- Patient Satisfaction Survey responses at 6 weeks(Week 6)
- Rate of severe hypertension(Week 6)
- Rate of new hypertension diagnosis at 6 weeks postpartum(Week 6)