Feasibility and Safety of Incorporating Telehealth Visits Combined With Remote Blood Pressure Monitoring in the Management of Chronic Hypertension in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of telehealth with remote BP telemonitoring compared to standard care
研究概览
简要总结
The purpose of this research study is to compare the management of chronic hypertension during pregnancy using telehealth visits with blood pressure telemonitoring and health coaching as compared to standard in person clinic visits. The study involves pregnant woman aged 18-45 who are receiving care for chronic hypertension. Participation in this research study will last until their baby is delivered. The number of in-person clinic visits depends on the participant's treatment assignment. Those assigned to telehealth visits will have telehealth visits alternating with clinic visits every two weeks until the end of pregnancy week 31. Those assigned to telehealth visits will also have five sessions with a health coach via telephone or video from the time of enrollment until the end of pregnancy week 36.
详细描述
Hypertension (HTN) in pregnancy requires weekly or bi-weekly in-person visits. Telehealth visits with remote blood pressure (BP) telemonitoring may be an alternative to frequent in-person visits improve adherence. However, the feasibility of this approach in pregnancy is lacking and studies are limited on the use of remote BP telemonitoring in chronic HTN (cHTN) during pregnancy. A digital health platform for BP management in pregnant women at risk for preeclampsia (women with cHTN, prior preeclampsia or kidney disease) found fewer admissions for HTN or suspected preeclampsia in the intervention compared to usual care. There is a critical need to investigate the feasibility (willingness and adherence), and safety of this intervention. Without ascertaining the feasibility of telehealth and remote BP monitoring, it remains a challenge to tackle the no-show rates and suboptimal medication adherence during pregnancy.
Objectives Aim 1: To determine the feasibility of incorporating telehealth clinic visits with remote BP telemonitoring alternating with in-person clinic visits in the management of cHTN in pregnancy in the clinic by evaluating willingness to enroll, completion rate and adherence versus standard care (in-person clinic visits alone). This working hypothesis is that this approach will be as feasible as standard care.
Aim 2: To explore safety outcomes of telehealth clinic visits combined with blood pressure remote telemonitoring alternating with in-person clinic visits in the management of chronic hypertension in pregnant patients in the clinic by measuring the incidence of hypotension, syncope or hospitalization/emergency room visits for severe HTN compared to standard care. The working hypothesis is that this approach will be comparable in safety to standard care.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •prior diagnosis of Chronic hypertension (cHTN)
- •Pregnant women
- •Known: documented diagnosis or on antihypertensive medication prior to pregnancy
排除标准
- •Any significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the study
- •Cardiac disorders: cardiomyopathy, angina, Coronary Artery Disease (CAD)
- •Current substance abuse disorder
- •Multifetal pregnancy
- •Participation in another study without prior approval
- •Plan to deliver outside Atrium Health Wake Forest Baptist
- •Prior stroke
- •Severe hypertension
- •Suspected or known fetal major structural/chromosomal abnormality or fetal demise
研究组 & 干预措施
Standard of Care
In person clinic visits
干预措施: In-person visits (Behavioral)
Telehealth Cycle
Participants in this arm will be provided telehealth visits in addition to the blood pressure telemonitoring.
干预措施: In-person visits (Behavioral)
Telehealth Cycle
Participants in this arm will be provided telehealth visits in addition to the blood pressure telemonitoring.
干预措施: Telehealth visits (Behavioral)
结局指标
主要结局
Feasibility of telehealth with remote BP telemonitoring compared to standard care
时间窗: Gestational Week 31
willingness to enroll (number of patients enrolled divided by number of patients reached), study completion rate, adherence compared to standard care). Adherence will be defined as taking medication at least ≥80% of the time, recording ≥70% of weekly BP readings in the intervention group only and completing ≥70% of antenatal telehealth/clinic visits.
Safety of telehealth combined with telemonitoring compared to standard care
时间窗: Gestational Week 31
The number of adverse events reported (hypotension, syncope or hospitalization/emergency room visit for severe HTN
次要结局
- Patient satisfaction Scores(Gestational Week 31)
- Clinical team member (Medical Assistant, Nursing staff, Medical Provider, Scheduler) satisfaction Scores(Gestational Week 31)