Telemedicine Management for High Blood Pressure

(TM-HTN Trial)

Overseen By Sunit Chhetri

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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Telemedicine management of Hypertension?

Research shows that telemedicine, which involves monitoring blood pressure from home and communicating with healthcare providers remotely, can help improve blood pressure control. Studies have found that this approach can lower blood pressure more effectively than usual care, making it a promising option for managing high blood pressure. ^{1 2 3 4 5}

Is telemedicine management for high blood pressure safe for humans?

The research does not provide specific safety data for telemedicine management of high blood pressure, but it suggests that using home blood pressure monitoring and telemedicine can be effective in managing hypertension, especially when in-person visits are not possible. ^{6 7 8 9 10}

How is the telemedicine treatment for high blood pressure different from other treatments?

This telemedicine treatment for high blood pressure is unique because it combines home blood pressure monitoring with remote support from healthcare professionals, allowing for personalized medication adjustments and lifestyle advice without needing in-person visits. This approach can improve patient awareness and adherence to treatment, especially useful during situations like the COVID-19 pandemic when face-to-face interactions are limited. ^{1 6 10 11 12}

What is the purpose of this trial?

Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control.

Research Team

Yashashwi Pokharel, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Telemedicine in the management of hypertension: Evolving technological platforms for blood pressure telemonitoring. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study). [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Heterogeneity of the Effect of Telemedicine Hypertension Management Approach on Blood Pressure: A Systematic Review and Meta-analysis of US-based Clinical Trials. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Home based telemedicine intervention for patients with uncontrolled hypertension--a real life non-randomized study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Managing hypertension in urban underserved subjects using telemedicine--a clinical trial. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Accuracy of blood pressure measurements transmitted through a telemedicine system in underserved populations. [2008]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Home Blood Pressure and Telemedicine: A Modern Approach for Managing Hypertension During and After COVID-19 Pandemic. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Evidence and Recommendations on the Use of Telemedicine for the Management of Arterial Hypertension: An International Expert Position Paper. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Simplified regimen for the management of hypertension with telemedicine and blood pressure self-monitoring (SIMPLE): study protocol for a randomised controlled trial. [2022]