Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).
详细描述
The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)
- •Live birth at any gestational age
- •Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)
排除标准
- •HELLP syndrome
- •History of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease)
- •Current Omron remote patient monitoring or Noom user
- •BMI<18.5 kg/m2 at enrollment
- •Inadequate gestational weight gain or gestational weight loss
研究组 & 干预措施
Usual Care (Control)
Participant will receive usual care.
Bundled digital health intervention
Participant will be enrolled in a digital blood pressure monitoring program and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care.
干预措施: Mobile health application (Other)
Bundled digital health intervention
Participant will be enrolled in a digital blood pressure monitoring program and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care.
干预措施: Digital Blood Pressure Monitoring System (Other)
结局指标
主要结局
Systolic blood pressure
时间窗: 3 months postpartum; 12 months postpartum
All participants will have systolic blood pressure measured at 3 months and 12 months postpartum
次要结局
- Weight(3 months postpartum; 12 months postpartum)
- Subclinical cardiovascular dysfunction via echocardiography(3 months postpartum; 12 months postpartum)
- Participant engagement(12 months postpartum)
- Study feasibility(12 months postpartum)
- Anti-hypertensive medication use (%)(3 months postpartum; 12 months postpartum)
研究者
Priya Freaney
Professor
Northwestern University