Telehealth and Remote Blood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
prior diagnosis of Chronic hypertension (cHTN)
Pregnant women
Known: documented diagnosis or on antihypertensive medication prior to pregnancy
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Telehealth visits
Behavioralremote visits with participants
In-person visits
Behavioralstandard of care visits with care provider in person
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Telehealth CycleExperimental treatment 2 interventions
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Gestational Week 312
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
Time frame
Gestational Week 31Secondary outcomes
1
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
Time frame
Gestational Week 312
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
Time frame
Gestational Week 31Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov