Telehealth and Remote Blood Pressure

NCT07356518 | Recruiting

• 1 other identifier: IRB00142349
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Hypertension in Pregnancy

Keywords

high blood pressure; pre-eclampsia; hypertension during pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient satisfaction Scores

  Gestational Week 31

• Clinical team member (Medical Assistant, Nursing staff, Medical Provider, Scheduler) satisfaction Scores

  Gestational Week 31

Study Arms (2)

Telehealth Cycle

EXPERIMENTAL

Participants in this arm will be provided telehealth visits in addition to the blood pressure telemonitoring.

Behavioral: Telehealth visits; Behavioral: In-person visits

Standard of Care

ACTIVE COMPARATOR

In person clinic visits

Behavioral: In-person visits

Interventions

Telehealth visits BEHAVIORAL

remote visits with participants

Telehealth Cycle

In-person visits BEHAVIORAL

standard of care visits with care provider in person

Standard of Care; Telehealth Cycle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aderonke O Adeniyi, MD, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ejiro Obioma, MBBS MMCi

CONTACT

704-355-2000; Ejiro.Obioma@Advocatehealth.org

Aderonke Adeniyi, MD, MS

CONTACT

337 713 2278; aderonke.adeniyi@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months and ending 36 months following article publication.
• 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.

Locations

US (1)