NCT07209254招募中不适用
Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension
Jennifer Lewey, MD, MPH3 个研究点 分布在 1 个国家目标入组 770 人开始时间: 2026年3月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 770
- 试验地点
- 3
- 主要终点
- Mean diastolic blood pressure (DBP)
研究概览
简要总结
A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥18 years
- •Delivery within 14 days
- •Diagnosis of preeclampsia or gestational hypertension with or without severe features during pregnancy or within 14 days postpartum
- •Initiation of blood pressure medication prior to hospital discharge and up to 14 days postpartum
- •English or Spanish speaking (able to read/understand consent and instructions)
- •Has phone texting capabilities
排除标准
- •Diagnosis of chronic hypertension prior to delivery (would therefore include super imposed preeclampsia)
- •Pre-existing cardiovascular disease (including prior myocardial infarction, stroke, heart failure with reduced ejection fraction, ventricular tachycardia, prior cardiac arrest, pacemaker, severe valvular heart disease, or prior cardiac surgery)
- •Chronic kidney disease (stage 3 or higher)
- •Using ≥3 BP medications at time of enrollment
研究组 & 干预措施
High-touch blood pressure management
Experimental
干预措施: High-touch blood pressure management (Other)
Low-touch blood pressure management
Experimental
干预措施: Low-touch blood pressure management (Other)
结局指标
主要结局
Mean diastolic blood pressure (DBP)
时间窗: 12 months postpartum
Assessed by 24-hour ambulatory blood pressure monitor (ABPM)
次要结局
- Blood pressure outcome: Mean nocturnal DBP(12 months postpartum)
- Blood pressure outcome: Mean systolic blood pressure (SBP)(12 months postpartum)
- Blood pressure outcome: Mean nocturnal SBP(12 months postpartum)
- Blood pressure outcome: Mean DBP(12 months postpartum)
- Chronic Hypertension(12 months postpartum)
- Echocardiogram Outcomes(12 months postpartum)
- Patient Reported Outcome - Patient Activation Measure(Post-randomization to 1 year postpartum)
- Patient Reported Outcome - Perceived Stress(Post-randomization to 1 year postpartum)
- Patient Reported Outcome - Self-Efficacy(Post randomization to 1 year postpartum)
- Implementation Outcome: Acceptability of Intervention(From 6 weeks postpartum through 1 year postpartum)
研究者
Jennifer Lewey, MD, MPH
Assistant Professor of Medicine (Cardiovascular Medicine)
University of Pennsylvania
研究点 (3)
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