Telehealth and Remote Blood Pressure

Официальное название

Feasibility and Safety of Incorporating Telehealth Visits Combined With Remote Blood Pressure Monitoring in the Management of Chronic Hypertension in Pregnancy

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Telehealth visits
  remote visits with participants
• Поведенческое In-person visits
  standard of care visits with care provider in person

Первичные конечные точки

• Feasibility of telehealth with remote BP telemonitoring compared to standard care [Срок оценки: Gestational Week 31]
• Safety of telehealth combined with telemonitoring compared to standard care [Срок оценки: Gestational Week 31]

Вторичные конечные точки (2)

• Patient satisfaction Scores [Срок оценки: Gestational Week 31]
• Clinical team member (Medical Assistant, Nursing staff, Medical Provider, Scheduler) satisfaction Scores [Срок оценки: Gestational Week 31]

Критерии участия

Критерии включения

• prior diagnosis of Chronic hypertension (cHTN)
• Pregnant women
• Known: documented diagnosis or on antihypertensive medication prior to pregnancy

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Wake Forest University Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT07356518 · IRB00142349

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗