Mobile Health Intervention for High Blood Pressure

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Disqualifiers: Critical illness, Incarcerated, Pregnant, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Emergency department visits provide an opportunity to identify people with undiagnosed, untreated, or uncontrolled high blood pressure. In Reach Out, we will test whether a mobile health intervention yields a greater reduction in blood pressure than usual care among individuals identified with high blood pressure during a safety-net emergency department visit. Subsequently, we will estimate the reduction in heart attack, stroke, and dementia if Reach Out were implemented across all U.S. safety-net emergency departments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for high blood pressure?

Research shows that self-measured blood pressure monitoring (SMBP) at home is effective in managing high blood pressure, as it helps patients keep track of their condition outside the clinic and improves patient engagement and outcomes. ^{1 2 3 4 5}

Is self-measured blood pressure monitoring (SMBP) safe for humans?

Self-measured blood pressure monitoring (SMBP) is generally considered safe for humans. It involves using validated devices that provide reliable readings, and it is widely used to manage high blood pressure effectively. ^{1 4 6 7 8}

How is the treatment Self-Measured Blood Pressure Monitoring (SMBP) unique for high blood pressure?

Self-Measured Blood Pressure Monitoring (SMBP) is unique because it allows patients to monitor their blood pressure at home using cellular-enabled devices, which do not require Wi-Fi or Bluetooth, and supports patient engagement through simple text messaging. This approach integrates into existing healthcare workflows, making it accessible and effective for managing high blood pressure, especially in underresourced communities. ^{2 3 4 5 9}

Eligibility Criteria

This trial is for individuals who visit the emergency department and are identified with high blood pressure, which may be undiagnosed, untreated, or uncontrolled. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am 18 years old or older.

Likely to be discharged from the ED

At least one BP with Systolic BP ≥160 or a Diastolic BP ≥100

Exclusion Criteria

Critical illness

Unable to read English (<1% at study site)

Pregnant

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of prompted self-monitored blood pressure (SMBP) monitoring with tailored feedback and facilitated primary care appointment and transportation

6 months

Every 4 weeks (in-person or virtual)

Extended Treatment

Participants enter an extended treatment period of long-term SMBP monitoring

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Physician appointment and transportation scheduling (Behavioral Intervention)
• Self-Measured Blood Pressure Monitoring (Behavioral Intervention)

Trial Overview The Reach Out trial tests a mobile health intervention that includes self-measured blood pressure monitoring and help with scheduling doctor appointments and transportation. It's compared to usual care to see if it better reduces blood pressure after an emergency department visit.

Participant Groups

Group I: REACH OUT Experimental Treatment 2 Interventions

REACH OUT messaging is based on BP control. Control is defined as SMBP \<135/85. Every 4 weeks SMBP measurements will be assessed and mHealth components will be escalated, de-escalated, or remain the same. If BP is controlled, SMBP prompts will be sent once a week and there will be no facilitated appointments. If BP is uncontrolled, SMBP prompts will be sent three times per week and facilitated provider scheduling and transportation will occur. Participants will have the option include a partner, friend, or family member with text-messaging capability who could support them on their BP journey. The partner will receive Reach Out materials and text messages to remind the participant to engage in SMBP and of their upcoming appointments (if uncontrolled).

Group II: Usual Care Group Active Control 1 Intervention

The usual care group is standard of care. They will receive the standard ED discharge materials available as recommended by their ED physician. These materials recommend lifestyle changes, dietary changes, medication as directed, and follow-up with a PCP as directed.

Self-Measured Blood Pressure Monitoring is already approved in China for the following indications:

Approved in China as Self-Measured Blood Pressure Monitoring for:

• Hypertension management
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

A study involving 478 hypertensive patients at community health centers showed that after implementing self-measured blood pressure monitoring (SMBP), patient engagement in managing their blood pressure significantly increased, with 77% knowing their ideal blood pressure levels.

85% of patients reported a positive experience with SMBP, indicating that with proper training and support, patients can effectively monitor their blood pressure at home, enhancing their care continuity, especially during challenging times like a pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Community Health Center Patients Interested in Self-Measured Blood Pressure Monitoring (SMBP) - And Can They Do It? Roy, D., Meador, M., Sasu, N., et al.[2022]

In a study of 224 patients with hypertension over 12 months, self-monitoring blood pressure (SMBP) led to a significant average decrease in systolic blood pressure by 2.5 mm Hg compared to usual care.

The most notable benefit of SMBP was observed in patients aged 60 years and older, where their uncontrolled blood pressure rates dropped from 90.9% at baseline to 38.2% at month 12, indicating SMBP is particularly effective for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Self-Monitoring Blood Pressure in Primary Care: A Randomized Controlled Trial. Aekplakorn, W., Suriyawongpaisal, P., Tansirisithikul, R., et al.[2018]

Self-measurement of blood pressure (SMBP) at home is an accurate method for diagnosing hypertension, showing higher specificity and predictive value compared to traditional office blood pressure measurements in a study of 64 untreated hypertensive patients.

The reproducibility of SMBP in standardized conditions is comparable to that of ambulatory blood pressure monitoring (ABPM), suggesting that with proper training, home measurements can be reliably used for hypertension diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Accuracy and precision in blood pressure measurement. Comparative study of home self-measurement with measurement in the clinic and out-patient monitoring]. Divisón, J., Puras, A., Sanchis, C., et al.[2020]

The study will evaluate the effectiveness of self-measured blood pressure monitoring (SMBP) using cellular-enabled devices in safety-net clinics, targeting patients with hypertension and aiming to improve blood pressure management without needing Wi-Fi or Bluetooth.

It will compare three levels of implementation support for SMBP, including minimal support, protocol-based reminders, and pharmacist-led coaching, to determine which approach best helps patients achieve better blood pressure control and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study. Fontil, V., Khoong, EC., Green, BB., et al.[2023]

Self-measurement of blood pressure (SMBP) significantly improved blood pressure control in patients with hypertension in the short term, with a 7.6% higher control rate at week 8 compared to usual care.

However, the effectiveness of SMBP diminished over time, with only a 4.9% difference in control rates remaining by the end of the study, indicating that ongoing support may be needed for sustained blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of self-measurement of blood pressure in patients with hypertension: the Dioampa study]. Dalfó i Baqué, A., Capillas Peréz, R., Guarch Rocarias, M., et al.[2023]

A survey of 1,590 primary care physicians and nurse practitioners revealed that 97% use self-measured blood pressure monitoring (SMBP), primarily for both diagnosis and treatment, indicating its widespread acceptance as a tool for managing hypertension.

Despite the high usage of SMBP, there are notable gaps in best practices, such as patient counseling on cuff size and device validation, suggesting that improvements in these areas could enhance the effectiveness of SMBP in blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Self-Measured Blood Pressure Monitoring, 2015-2016. Jackson, SL., Ayala, C., Tong, X., et al.[2021]

In a study of 159,536 US adults, 33.9% reported having hypertension, and nearly 70% of those were advised by healthcare professionals to use self-measured blood pressure (SMBP) monitoring.

Approximately 61% of individuals with hypertension reported actually using SMBP, primarily at home, and over 80% shared their readings with healthcare professionals, indicating a strong engagement in self-management of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Measured Blood Pressure Monitoring Among Adults With Self-Reported Hypertension in 20 US States and the District of Columbia, 2019. Fang, J., Luncheon, C., Wall, HK., et al.[2023]

Self-measurement of blood pressure (SMBP) using validated automated devices provides reliable readings and is particularly useful for evaluating antihypertensive treatments, especially in cases of resistant hypertension and the white-coat effect.

SMBP not only enhances patient motivation and adherence to treatment but also improves the power of clinical trials, allowing researchers to detect smaller differences in blood pressure with fewer participants compared to traditional office measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-measurement of blood pressure in clinical trials and therapeutic applications. Denolle, T., Waeber, B., Kjeldsen, S., et al.[2007]

The Reach Out mHealth intervention, which uses SMS text messaging for self-measured blood pressure (SMBP) monitoring, was well-received by participants, indicating its potential effectiveness in engaging hypertensive patients in managing their blood pressure.

Participants with higher engagement levels had better understanding and social support, while those with lower engagement or who withdrew from the trial faced more health-related social needs, suggesting that addressing these needs could improve participation and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study. Hellem, AK., Whitfield, C., Casetti, A., et al.[2023]

References

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

Are Community Health Center Patients Interested in Self-Measured Blood Pressure Monitoring (SMBP) - And Can They Do It? [2022]

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

Effectiveness of Self-Monitoring Blood Pressure in Primary Care: A Randomized Controlled Trial. [2018]

3. Spain pubmed.ncbi.nlm.nih.gov

[Accuracy and precision in blood pressure measurement. Comparative study of home self-measurement with measurement in the clinic and out-patient monitoring]. [2020]

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

Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of self-measurement of blood pressure in patients with hypertension: the Dioampa study]. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Self-Measured Blood Pressure Monitoring, 2015-2016. [2021]

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

Self-Measured Blood Pressure Monitoring Among Adults With Self-Reported Hypertension in 20 US States and the District of Columbia, 2019. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Self-measurement of blood pressure in clinical trials and therapeutic applications. [2007]

9. Canada pubmed.ncbi.nlm.nih.gov

Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study. [2023]