Mobile Health Intervention for High Blood Pressure

Overseen By William Meurer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Critical illness, Incarcerated, Pregnant, 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: 4

Duration: 6 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile health app can lower high blood pressure more effectively than standard care. Participants will monitor their blood pressure at home using Self-Measured Blood Pressure Monitoring (SMBP) and receive tailored support through text messages. The study will also explore the potential to reduce heart attacks, strokes, and dementia if this approach is widely adopted. It suits individuals who have been diagnosed with high blood pressure during an emergency room visit, own a cellphone with texting capabilities, and are likely to return home after the visit. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could transform future healthcare practices.

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 prior data suggests that this mobile health intervention is safe for managing high blood pressure?

Research shows that checking blood pressure at home, known as self-measured blood pressure monitoring (SMBP), is a safe and effective way to track blood pressure. It can detect high blood pressure earlier and provides more accurate results than readings taken at the doctor's office. This accuracy arises because it avoids "white coat hypertension," where stress in a medical setting raises blood pressure. SMBP also confirms high blood pressure by offering more readings over time.

Regarding the safety of mobile health tools, earlier studies on using technology for scheduling appointments and providing transportation have not identified any major safety issues. Ensuring easy access to doctor's appointments is crucial for managing high blood pressure.

These methods are generally well-received, with no major problems reported. For those considering joining a trial using these methods, current evidence suggests they are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Intervention for High Blood Pressure because it leverages technology to personalize and enhance patient care. Unlike standard treatment options, which often include lifestyle changes, medication, and regular doctor visits, this approach uses self-measured blood pressure monitoring (SMBP) combined with mobile health (mHealth) messaging. The unique feature here is the adaptive communication: if blood pressure is controlled, reminders are minimal, but if it's uncontrolled, more frequent prompts and additional support like appointment scheduling and transportation are offered. This personalized and dynamic method could significantly improve adherence and outcomes by actively engaging patients and their support networks in their treatment journey.

What evidence suggests that this mobile health intervention is effective for high blood pressure?

Research shows that checking blood pressure at home, known as Self-Measured Blood Pressure Monitoring (SMBP), can help lower it. Studies of various trials have found that individuals who regularly monitor their blood pressure at home experience noticeable improvements. This trial will test SMBP as part of the REACH OUT arm, where participants receive prompts based on their blood pressure control. Additionally, the REACH OUT arm includes facilitated scheduling of doctor visits and transportation for those with uncontrolled blood pressure, improving follow-up care. Together, these strategies can lead to better blood pressure control and may lower the risk of heart attacks and strokes. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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

Likely to be discharged from the ED

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

My blood pressure stayed high even after treatment.

Exclusion Criteria

Critical illness

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

Pregnant

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Physician appointment and transportation scheduling
• Self-Measured Blood Pressure Monitoring

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.

How Is the Trial Designed?

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 United States, European Union, China for the following indications:

Approved in United States as Self-Measured Blood Pressure Monitoring for:

• Hypertension management
• Blood pressure monitoring

Approved in European Union as Self-Measured Blood Pressure Monitoring for:

• Hypertension management
• Cardiovascular risk reduction

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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]

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]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009606

Reach Out Emergency Department: A Randomized ... We also sought to determine the effect of facilitated primary care provider appointment scheduling and transportation on primary care follow-up.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7479966/

Reach Out Emergency Department The Reach Out behavioral intervention consists of three components: healthy behavior, blood pressure self-monitoring prompts, and PCP appointment and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03422718

Reach Out: Emergency Department-Initiated Hypertension ... Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7268693/

Reach out behavioral intervention for hypertension initiated in ... Aim 2: The effect of PCP appointment scheduling and transportation on primary care follow-up of hypertensive patients initiated from an urban, safety net ED.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04340-z

Reach out behavioral intervention for hypertension initiated in ... Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37192282/

Reach Out Emergency Department: A Randomized Factorial ... Reach Out is an mHealth, health theory-based, 2×2×2 factorial trial among hypertensive patients evaluated in a safety-net Emergency Department in Flint, ...

7. ahajournals.org ahajournals.org/doi/pdf/10.1161/CIRCOUTCOMES.122.009606

Reach Out Emergency Department Regarding medical care and hypertension factors, 22% did not have a primary care doctor; 10% were uninsured; 21% lacked transportation to a PCP appointment in ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2671405

Association of Rideshare-Based Transportation Services ... Objective To evaluate the association between rideshare-based medical transportation and missed primary care appointments among Medicaid ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6450539/

A systematic review of interventions to minimize transportation ... We synthesized evidence concerning the types and impact of interventions that address transportation to chronic care management.