Telehome Monitoring for High Blood Pressure

(HTMTHM Trial)

Overseen By Evyanne Quirouette

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Specialized HTN care, Pregnancy, Institutionalized, Travel, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special home blood pressure monitor and program, known as Telehome Monitoring, can help individuals manage high blood pressure more effectively from home. As more doctor visits occur online, many people find it challenging to check their blood pressure accurately. The study evaluates whether this new system can improve blood pressure control and prevent health problems associated with hypertension. Individuals with high blood pressure and a reliable phone connection at home may be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions from the comfort of home.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment, as the study focuses on monitoring blood pressure at home.

What prior data suggests that this telehome monitoring is safe for managing high blood pressure?

Research has shown that remote patient monitoring, such as telehome monitoring, is generally safe and aids in managing high blood pressure. Studies have found that telehealth programs improve blood pressure control, indicating patients handle the technology well.

Remote monitoring automatically tracks blood pressure changes, helping to detect potential heart problems early. This method proves effective without causing serious side effects. Patients using remote monitoring have reported better blood pressure management, demonstrating that this approach is both helpful and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telehome monitoring for high blood pressure because it offers a new way to manage the condition from the comfort of your home. Unlike traditional treatments that rely solely on periodic doctor visits, this approach uses a digital platform to track daily blood pressure readings and adjust medications in real-time, allowing for more personalized and timely care. The unique feature of telehome monitoring is its capacity to provide continuous oversight by healthcare professionals, potentially leading to better blood pressure control and a reduction in complications associated with hypertension.

What evidence suggests that telehome monitoring is effective for managing high blood pressure?

Research has shown that monitoring health from home can help control blood pressure. In this trial, participants in the intervention arm will use telehome monitoring, a form of remote patient monitoring (RPM), which studies have shown leads to better management of high blood pressure. One study discovered that a remote health program improved blood pressure control by encouraging regular home checks. However, another study suggested that remote monitoring alone might not always improve blood pressure without additional support. Overall, evidence supports home monitoring as an effective tool for managing high blood pressure. ^{1 3 6 7 8}

Who Is on the Research Team?

Hassan Mir, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with primary, essential high blood pressure who can speak English or French and have access to a phone and a cellular network at home. It's not for those managed at specialized clinics, planning extensive travel, pregnant women, residents in long-term care facilities, or those with cognitive impairments.

Inclusion Criteria

Have access to a phone (can be a landline)

You have been diagnosed with high blood pressure.

You need to have access to a 4G cellular network at your home to use the Aetonix aTouchAway platform, even if you don't have your own cellphone.

Exclusion Criteria

You are currently being treated for high blood pressure at a special clinic or through a remote monitoring program.

Patients who plan on travelling out of the country for more than 2 weeks at any point during the intervention phase of the study (first 3 months)

Women who are pregnant, breastfeeding or planning to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a home monitoring device for blood pressure management and are monitored by a telehome nursing team. Medication titration occurs every 2 weeks if needed.

3 months

Daily virtual monitoring

Control

Participants continue usual activities, receive educational materials, and track blood pressure at home.

3 months

Daily self-monitoring

Follow-up

Participants are monitored for maintenance of blood pressure control effects after the intervention.

3 months

1 visit (virtual) for 24-hour ABPM

What Are the Treatments Tested in This Trial?

Interventions

• Telehome Monitoring

Trial Overview The study tests if a special blood pressure cuff and remote monitoring program can help patients manage their high blood pressure better during times when healthcare is mostly virtual due to the COVID-19 pandemic.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will be asked to continue their usual day to day activities and take their current medications as directed. They will be sent a link by email or through MyChart to the educational session described above in the control group section. They will receive an Aetonix aTouchAway platform monitor, which is a disease specific home monitoring device to take home for 3 month intervention period. The device will prompt the participant to check their blood pressure on a daily basis and will send all readings to the UOHI Telehome monitoring program. The telehome monitoring nursing team will monitor the readings for each participant. For hypertensive patients who are not at target with their BP, the telehome monitoring nurse will titrate medications based on an advanced medical directive every 2 weeks. Patients will be provided instructions of when they should seek medical attention (clinical symptoms or SBP \<100 or SBP \>160).

Group II: Control Active Control 1 Intervention

Participants will be asked to continue their usual day to day activities and take their current medications as directed. They will be sent a link by email or through MyChart to the standard video \& education session on managing hypertension. They will watch the video at home on their own time. Participants will use a home blood pressure monitor to track their blood pressure (those without a blood pressure cuff will be provided one) for the 3-month intervention period. Patients will be provided instructions of when they should seek medical attention (clinical symptoms or SBP \<100 or SBP \>160). They will be encouraged to track their blood pressure daily and any symptoms they may be feeling.

Telehome Monitoring is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Telehome Monitoring for:

• Hypertension management
• Chronic disease management

Approved in Canada as Remote Patient Monitoring for:

• Hypertension management
• Cardiovascular care

Approved in European Union as Telehealth Monitoring for:

• Hypertension management
• Chronic disease management
• Cardiovascular care

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

Ambulatory blood pressure monitoring is essential for managing hypertension, and home monitoring is preferred by patients, highlighting the importance of patient-centered approaches in treatment.

Despite the rise of smartphone apps for blood pressure monitoring, only two apps align with European Society of Hypertension guidelines, indicating a need for better collaboration between tech developers and healthcare professionals to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure measurement and digital health: communication technologies create a new context. Postel-Vinay, N., Bobrie, G., Savard, S., et al.[2019]

Blood pressure telemonitoring (BPT) combined with telecounseling and case management significantly reduces blood pressure in high-risk patients compared to usual care, based on evidence from several randomized controlled trials.

While BPT shows promise in improving hypertension management and patient self-care, most studies are short-term (less than 12 months), and there is no consensus on the best BPT healthcare delivery model due to varied interventions and technologies used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure telemonitoring in the 21st century. Parati, G., Dolan, E., McManus, RJ., et al.[2022]

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]

A novel reflective photoplethysmography (PPG) sensor was developed, achieving nearly 98% accuracy in noninvasive continuous blood pressure measurement, making it a reliable option for remote healthcare monitoring.

This system is designed to be user-friendly and cost-effective, with potential applications for monitoring blood pressure in vulnerable populations such as infants, the elderly, and patients with injuries or in intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Universal Noninvasive Continuous Blood Pressure Measurement System for Remote Healthcare Monitoring. Mukherjee, R., Ghosh, S., Gupta, B., et al.[2019]

Home blood pressure monitoring (HBPM) is an effective self-monitoring tool for managing hypertension, leading to better blood pressure control and helping to identify conditions like white-coat hypertension, as supported by a growing body of evidence.

New HBPM technology features a longer inflatable cuff that improves accuracy by allowing for better placement on the arm, addressing the common issue of inaccurate readings in traditional monitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Blood Pressure Monitoring. George, J., MacDonald, T.[2022]

Remote ambulatory blood pressure monitoring (ABPM) can be safely and effectively conducted without face-to-face contact, as demonstrated by a study involving 65 participants, where 88% successfully completed the monitoring.

The study found no significant difference in measurement success rates between remote (88%) and face-to-face (89%) ABPM, indicating that remote methods can provide comparable results in hypertension management during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure monitoring using telemedicine: proof-of-concept cohort and failure modes and effects analyses. Armitage, LC., Lawson, BK., Roman, C., et al.[2022]

Blood pressure telemonitoring (BPT) has strong evidence supporting its effectiveness in screening, diagnosing, and managing hypertension, especially when combined with interventions from healthcare professionals and education on lifestyle changes.

BPT can lead to improved treatment compliance, better blood pressure control, enhanced quality of life, and potential cost savings, indicating it may significantly transform hypertension management in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-Health in Hypertension Management: an Insight into the Current and Future Role of Blood Pressure Telemonitoring. Omboni, S., Panzeri, E., Campolo, L.[2020]

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11353537/

Remote Patient Monitoring Is Associated with Improved ... RPM is associated with improved HTN control and provides further evidence supporting telehealth programs which can aid in chronic disease management.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9903197/

Is remote blood pressure monitoring and management a ... The development of telemedicine has promoted better blood pressure monitoring and management for patients, as well as better medical intervention and health ...

3. telehealth.hhs.gov telehealth.hhs.gov/documents/ResearchRecap-Telehealth_and_RPM_09-30-24.pdf

Telehealth Research Recap: Remote Patient Monitoring Remote patient monitoring (RPM) facilitates the real-time collection and transmission of health data from a patient to the health care provider.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819402

Remote Blood Pressure Monitoring With Social Support for ... Findings of this trial indicate that neither remote monitoring of BP alone nor combined with social support result in improved BP control in adults with ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.027296

Remote Cardiovascular Hypertension Program Enhanced ... A remote clinical management program was successfully adapted and delivered significant improvements in BP control and increased home BP monitoring.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05300503

NCT05300503 | Evaluating the Use of a Remote Telehome ... Evaluating the Use of a Remote Telehome Monitoring Hypertension Program for Patients Receiving Virtual Care (HTMTHM). ClinicalTrials.gov ID NCT05300503.

7. nature.com nature.com/articles/s41371-023-00850-w

Blood pressure outcomes at 12 months in primary care ... Remote patient monitoring (RPM) for hypertension enables automatic transmission of blood pressure (BP) and pulse into the electronic health ...

8. academic.oup.com academic.oup.com/ajh/advance-article/doi/10.1093/ajh/hpaf097/8154826

Remote Blood Pressure Monitoring: A Comprehensive Review This technology at home allows for the detection of instantaneous fluctuations in BP that could be predictive of cardiovascular disease events.