Hypertension, Hypertension in Pregnancy
Conditions
Keywords
high blood pressure, pre-eclampsia, hypertension during pregnancy
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.
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
BEHAVIORALTelehealth visits
remote visits with participants
BEHAVIORALIn-person visits
standard of care visits with care provider in person
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of telehealth with remote BP telemonitoring compared to standard care | 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 | Gestational Week 31 | The number of adverse events reported (hypotension, syncope or hospitalization/emergency room visit for severe HTN |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction Scores | Gestational Week 31 | 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 |
| Clinical team member (Medical Assistant, Nursing staff, Medical Provider, Scheduler) satisfaction Scores | Gestational Week 31 | 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 |
Countries
United States
Contacts
CONTACTEjiro Obioma, MBBS MMCi
CONTACTAderonke Adeniyi, MD, MS
PRINCIPAL_INVESTIGATORAderonke O Adeniyi, MD, MS
Wake Forest University Health Sciences
Outcome results
None listed