HypertensionNCT07356518
Telehealth and Remote Blood Pressure
A study testing Telehealth visits and In-person visits in people with Hypertension and Hypertension in Pregnancy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypertension, Hypertension in Pregnancy
- What is being tested?
- Telehealth visits and In-person visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- prior diagnosis of Chronic hypertension (cHTN)
- Pregnant women
- Known: documented diagnosis or on antihypertensive medication prior to pregnancy
Who cannot join
- 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
Show all 9Show fewer
- Prior stroke
- Severe hypertension
- Suspected or known fetal major structural/chromosomal abnormality or fetal demise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Ejiro Obioma, MBBS MMCi, 704-355-2000, Ejiro.Obioma@Advocatehealth.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Hypertension in Pregnancy
- Being tested
- Telehealth visits, In-person visits
- Keywords
- high blood pressure, pre-eclampsia, hypertension during pregnancy
- Medical subject headings
- Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth visitsBehavioural
remote visits with participants
In-person visitsBehavioural
standard of care visits with care provider in person
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Cycle | Experimental | Participants in this arm will be provided telehealth visits in addition to the blood pressure telemonitoring. Receives: Behavioral: Telehealth visits; Behavioral: In-person visits |
| Standard of Care | Active comparator | In person clinic visits Receives: Behavioral: In-person visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Gestational Week 31
Secondary outcomes (2)
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
Measured: 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
Measured: Gestational Week 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start22 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aderonke O Adeniyi, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356518
- Sponsor's protocol ID
- IRB00142349
- Status last verified
- Dec 2025
- First submitted
- 12 Jan 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in this article, after de-identification (text, tables and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Incorporating Telehealth Visits Combined With Remote Blood Pressure Monitoring in the Management of Chronic Hypertension in Pregnancy
- ClinicalTrials.gov ID
- NCT07356518
- Acronym / sponsor ID
- IRB00142349
- Conditions
- Hypertension, Hypertension in Pregnancy
- Keywords
- high blood pressure, pre-eclampsia, hypertension during pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Cycle | Experimental | Behavioral: Telehealth visits, Behavioral: In-person visitsParticipants in this arm will be provided telehealth visits in addition to the blood pressure telemonitoring. |
| Standard of Care | Active comparator | Behavioral: In-person visitsIn person clinic visits |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- prior diagnosis of Chronic hypertension (cHTN)
- Pregnant women
- Known: documented diagnosis or on antihypertensive medication prior to pregnancy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth visitsremote visits with participants | Behavioural | Telehealth Cycle |
| In-person visitsstandard of care visits with care provider in person | Behavioural | Standard of Care, Telehealth Cycle |
Primary outcome
Feasibility of telehealth with remote BP telemonitoring compared to standard care
Time frame: 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
Time frame: Gestational Week 31
The number of adverse events reported (hypotension, syncope or hospitalization/emergency room visit for severe HTN
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in this article, after de-identification (text, tables and appendices)
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aderonke O Adeniyi, MD, MS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth visits and In-person visits in people with Hypertension and Hypertension in Pregnancy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ejiro Obioma, MBBS MMCi (704-355-2000, Ejiro.Obioma@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of telehealth with remote BP telemonitoring compared to standard care (time frame: Gestational Week 31). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.