Telehealth and Remote Blood Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telehealth visits, In-person visits.
- Who it may be relevant to
- Registry conditions: Hypertension, Hypertension in Pregnancy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Safety of Incorporating Telehealth Visits Combined With Remote Blood Pressure Monitoring in the Management of Chronic Hypertension in Pregnancy
Overview
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.
Detailed description
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.
Interventions
- Behavioral Telehealth visits
remote visits with participants - Behavioral In-person visits
standard of care visits with care provider in person
Primary outcome measures
- Feasibility of telehealth with remote BP telemonitoring compared to standard care [Time frame: Gestational Week 31]
- Safety of telehealth combined with telemonitoring compared to standard care [Time frame: Gestational Week 31]
Secondary outcome measures (2)
- Patient satisfaction Scores [Time frame: Gestational Week 31]
- Clinical team member (Medical Assistant, Nursing staff, Medical Provider, Scheduler) satisfaction Scores [Time frame: Gestational Week 31]
Eligibility criteria
Inclusion criteria
- prior diagnosis of Chronic hypertension (cHTN)
- Pregnant women
- Known: documented diagnosis or on antihypertensive medication prior to pregnancy
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT07356518 · IRB00142349