Telehealth and Remote Blood Pressure

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Hypertension in Pregnancy
• Intervention / Treatment: Behavioral: Telehealth visits; Behavioral: In-person visits

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ejiro Obioma, MBBS MMCi; Phone Number: 704-355-2000; Email: Ejiro.Obioma@Advocatehealth.org
• Study Contact Backup: Name: Aderonke Adeniyi, MD, MS; Phone Number: 337 713 2278; Email: aderonke.adeniyi@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Ejiro Obioma, MBBS MMCi; Phone Number: 704-355-2000; Email: Ejiro.Obioma@Advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth Cycle; Participants in this arm will be provided telehealth visits in addition to the blood pressure telemonitoring.	Behavioral: Telehealth visits; remote visits with participants; Behavioral: In-person visits; standard of care visits with care provider in person
Active Comparator: Standard of Care; In person clinic visits	Behavioral: In-person visits; standard of care visits with care provider in person

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of telehealth with remote BP telemonitoring compared to standard care	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.	Gestational Week 31
Safety of telehealth combined with telemonitoring compared to standard care	The number of adverse events reported (hypotension, syncope or hospitalization/emergency room visit for severe HTN	Gestational Week 31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction Scores	at the end of 31 weeks, each participant will complete a patient research satisfaction survey - Strongly disagree 0, disagree 1, neither agree nor disagree 2, agree 3, strongly agree 4	Gestational Week 31
Clinical team member (Medical Assistant, Nursing staff, Medical Provider, Scheduler) satisfaction Scores	at the end of 31 weeks, each provider of record for each participant will be invited to complete a research satisfaction survey. Nurses, medical assistants, schedulers at the Comprehensive Fetal Care Center who have participated in the telehealth visit with remote monitoring will be invited to complete a research satisfaction survey - Strongly disagree 0, disagree 1, neither agree nor disagree 2, agree 3, strongly agree 4	Gestational Week 31

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Aderonke O Adeniyi, MD, MS, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pre-eclampsia; high blood pressure; hypertension during pregnancy
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
• Other Study ID Numbers: IRB00142349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underline the results reported in this article, after de-identification (text, tables and appendices)
• IPD Sharing Time Frame: Beginning 12 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of data has been approved by an independent review committee identified for this purpose.

For what types of analysis: to achieve aims of the approval proposal and for individual participant data meta-analysis.

By what mechanism will data become available: Proposals may be submitted up to 36 months. After 36 months the data will be available in our University's data warehouse.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No