Telemedicine Management for High Blood Pressure

(TM-HTN Trial)

Overseen By Camelia Singletary, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Blood pressure

Disqualifiers: Chronic kidney disease, Atrial fibrillation, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether telemedicine can manage high blood pressure more effectively than traditional clinic visits. The goal is to determine if using a home blood pressure monitor, combined with telehealth support, can enhance self-care and better control blood pressure. Individuals who are African American or Black, have high blood pressure (consistent readings over 140), and have been on stable medication for at least six weeks might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative ways to manage health from home.

Will I have to stop taking my current medications?

The trial requires that participants have been on stable blood pressure medications for at least 6 weeks before joining, so you will not need to stop taking your current medications.

What prior data suggests that telemedicine management for hypertension is safe?

Research has shown that using telemedicine to manage high blood pressure is generally safe. One study found that telemedicine helps lower blood pressure without causing major issues. Another study demonstrated that people using digital health tools experienced a greater reduction in a key blood pressure measure over six months.

These studies indicate that telemedicine is safe and effective for controlling blood pressure. Notably, telemedicine is already recommended for managing long-term conditions like high blood pressure, suggesting that patients generally handle it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telemedicine management for high blood pressure because it offers a modern twist on traditional hypertension care. Unlike standard treatments that rely on regular clinic visits, this approach utilizes home blood pressure monitoring combined with telehealth applications, allowing for continuous, real-time management. This method empowers patients with self-management support and additional in-person training, potentially leading to improved adherence and better blood pressure control. By integrating technology, this approach aims to make managing hypertension more convenient and personalized, which could lead to better health outcomes.

What evidence suggests that telemedicine management is effective for high blood pressure?

This trial will compare telemedicine management of hypertension with usual care. Research has shown that telemedicine can effectively manage high blood pressure. People using telemedicine often experience a greater drop in blood pressure compared to those who only visit clinics. For instance, one study found that digital health tools led to a 4.24 mm Hg greater reduction in systolic blood pressure (the top number in a blood pressure reading). Another study found that telemedicine improved blood pressure control and increased patient satisfaction. While some uncertainty remains about its everyday use, evidence suggests telemedicine is a promising way to lower blood pressure and improve health. ^{1 2 5 6 7}

Who Is on the Research Team?

Yashashwi Pokharel, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for African American or Black patients experiencing social disadvantage, with stable high blood pressure medication use in the last 6 weeks. They must have a history of high systolic BP readings and be able to measure their BP at home. Excluded are those with severe hypertension, certain heart conditions, recent acute health changes, terminal illness, advanced kidney disease, or language barriers.

Inclusion Criteria

Subjects must be experiencing social disadvantage

Subjects must be African American or Black

My blood pressure medication has not changed in the last 6 weeks.

Exclusion Criteria

Diminished ability to measure home Blood Pressure

My blood pressure is not higher than 180/110 mmHg.

I have ongoing atrial fibrillation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive telemedicine management of hypertension, including home BP monitoring, pharmacotherapy, and telemedicine-based self-management support

6 months

Regular telemedicine sessions and home BP monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Telemedicine management of Hypertension
• Usual Care

Trial Overview The study compares two ways to manage high blood pressure: one uses telemedicine to support patient self-care between clinic visits; the other follows usual care practices without additional telemedicine support. The goal is to see if telemedicine can better control blood pressure.

How Is the Trial Designed?

Group I: Telemedicine management of Hypertension intervention group Experimental Treatment 1 Intervention

BP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training

Group II: control group Placebo Group 1 Intervention

This includes usual clinic based Hypertension care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Home blood pressure telemonitoring (HBPT) significantly lowers both systolic and diastolic blood pressure compared to usual care, with reductions of approximately 4.0 mmHg and 2.0 mmHg, respectively, based on a review of 46 randomized controlled trials involving 13,875 participants.

Patients using HBPT are more likely to achieve normalized blood pressure levels, and the intervention is even more effective when combined with additional support like counseling and education, suggesting that proactive engagement enhances its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. Duan, Y., Xie, Z., Dong, F., et al.[2023]

Home blood pressure telemonitoring significantly reduced office blood pressure in hypertensive patients, with an average decrease of 5.64 mm Hg systolic and 2.78 mm Hg diastolic, based on 12 studies involving 4,389 participants.

Patients using telemonitoring had a 31% higher chance of normalizing their blood pressure compared to those receiving usual care, although the technique also led to a slight increase in the use of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of home blood pressure telemonitoring and blood pressure control: a meta-analysis of randomized controlled studies. Omboni, S., Guarda, A.[2011]

Hypertension is a significant global health issue that impacts both physical and mental well-being, highlighting the need for effective long-term management strategies.

Telemedicine has emerged as a valuable tool for improving blood pressure monitoring and management, facilitating better patient-doctor cooperation and enhancing health education for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is remote blood pressure monitoring and management a better approach for patients with hypertension? A narrative review. Li, Y., Jiang, Y., Tang, Y.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11578275/

The Role of Telemedicine in Improving Hypertension ... These studies suggest that telemedicine can lead to improved blood pressure control, increased patient satisfaction, and reduced healthcare ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815070

Digital Health Interventions for Hypertension Management ... At 6 months of follow-up, individuals who received a digital health intervention had a 4.24 mm Hg greater reduction in SBP compared with those ...

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.15873

Evidence and Recommendations on the Use of ... Telemedicine has been shown to improve blood pressure (BP) control as compared with standard care, its place in daily clinical practice is not yet clear.

4. thecardiologyadvisor.com thecardiologyadvisor.com/news/telemedicine-management-hypertension-effective-bp-control/

Telemedicine Management of Hypertension Effective for ... The primary outcomes were differences in systolic BP (SBP), diastolic BP (DBP), and trial-defined BP control rate in telemedicine management of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07089290

A Study Protocol to Assess the Effectiveness of Nurse-Led ... A study in Nepal assessed the effectiveness of mobile phone text messaging intervention where SBP was decreased by 6.5mmHg and diastolic blood pressure (DBP) ...

6. cdc.gov cdc.gov/cardiovascular-resources/php/data-research/telehealth.html

Telehealth Interventions to Improve Chronic Disease The Community Preventive Services Task Force (CPSTF) recommends several telehealth interventions for reducing chronic disease risk factors in patients.

7. cardio.jmir.org cardio.jmir.org/2021/2/e27347

Efficacy of Telemedicine in Hypertension Care Through Home ... The results of this and previous studies suggest that telemedicine is reasonably safe for use in controlling BP in uncomplicated hypertension.