HTN App for High Blood Pressure

Overseen By Ashton Krogman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Serious medical condition, disability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 11 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial tests a new app called FAITH! HTN, designed to help African-American adults manage high blood pressure (hypertension) more effectively. The researchers aim to determine if the app can better control high blood pressure compared to regular care alone. Participants will either use the app for 11 weeks or receive standard care. This trial targets African-American adults with uncontrolled high blood pressure who are patients at specific clinics in Minneapolis and have access to a smartphone and the internet.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance hypertension management for the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the study focuses on using an app to help manage high blood pressure.

What prior data suggests that the FAITH! HTN app is safe for use in managing hypertension?

Research has shown that digital health tools, such as the FAITH! HTN app, can help manage high blood pressure. Studies have found that these tools can lower blood pressure. However, specific safety information for the FAITH! HTN app is not available. As a digital tool, it is likely safe to use, as apps typically do not cause side effects like medicine. Nonetheless, without clear safety data, consulting a doctor before starting any new treatment is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for high blood pressure, which typically includes medications like ACE inhibitors, beta-blockers, and lifestyle changes, the FAITH! HTN app offers a digital intervention. Researchers are excited about this app because it provides a personalized and interactive approach to managing hypertension, specifically tailored for African American adults. The app guides users through an 11-week intervention, aiming to improve adherence to lifestyle changes and medication, potentially offering a more engaging and accessible way to control blood pressure. By leveraging technology, this app could empower patients to take a more active role in their health management.

What evidence suggests that the FAITH! HTN app is effective for improving uncontrolled hypertension?

Research has shown that digital health tools can help lower blood pressure. For example, people using these tools experienced a 4.24 mm Hg greater drop in blood pressure compared to those who didn't use them. This trial specifically tests the FAITH! HTN app to help African American patients manage high blood pressure. Users have rated the app 9 out of 10 for supporting their self-care in managing hypertension. These positive results suggest that the app could effectively improve blood pressure control. ^{1 2 3 6 7}

Who Is on the Research Team?

LaPrincess C Brewer, MD, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for African-American individuals with uncontrolled high blood pressure. Participants should be interested in using an app to help manage their condition and must be willing to follow the study procedures over a period of at least 6 months.

Inclusion Criteria

African-American (AA) adults that are established patients at Neighborhood HealthSource in Minneapolis, Minnesota

Access to the Internet on at least a weekly basis

Active email address and willingness to utilize it throughout the study

Exclusion Criteria

I do not have a condition that makes it hard for me to participate in studies.

No primary care provider at partnering FQHC

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group complete an 11-week guided intervention using the FAITH! HTN app

11 weeks

Home-based intervention with virtual check-ins

Follow-up

Participants are monitored for changes in blood pressure and self-care activities at immediate, 3 months, and 6 months post-intervention

6 months

In-person and virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

• FAITH! HTN app

Trial Overview The FAITH! HTN app is being tested to see if it can improve blood pressure control and self-care among African-Americans with hypertension, compared to standard care. The effectiveness will be measured immediately after, at 3 months, and at 6 months post-intervention.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

African American adults with uncontrolled hypertension (HTN) will be assigned to complete an 11 week guided intervention using the FAITH! HTN app.

Group II: Control Group Active Control 1 Intervention

African American adults with uncontrolled hypertension (HTN) will receive the standard of care of HTN management.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Miami Heart Research Institute Inc.

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

A study analyzing the top 107 hypertension-related apps found that 72% offer tracking functions for blood pressure and other health metrics, but only 14% can function as medical devices to measure blood pressure, and none were validated against a gold standard.

Despite the popularity of apps claiming to measure blood pressure, with a strong correlation to downloads and positive reviews, there is a significant lack of oversight and validation in their development, highlighting a need for improved standards in hypertension management apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A content analysis of smartphone-based applications for hypertension management. Kumar, N., Khunger, M., Gupta, A., et al.[2022]

In a study involving 333 participants with uncontrolled hypertension, a smartphone coaching app aimed at promoting self-management did not significantly lower systolic blood pressure compared to a standard blood pressure tracking app after 6 months, with both groups showing similar blood pressure levels.

However, participants using the coaching app reported greater self-confidence in managing their blood pressure, suggesting potential psychological benefits that could support long-term hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Home Blood Pressure Monitoring via a Smartphone Hypertension Coaching Application or Tracking Application on Adults With Uncontrolled Hypertension: A Randomized Clinical Trial. Persell, SD., Peprah, YA., Lipiszko, D., et al.[2020]

Out of numerous hypertension self-management apps, only 5 were identified as potentially effective and secure, based on criteria like effectiveness, theoretical support, and data privacy.

The Cora Health app was rated the highest among the shortlisted apps by both doctors and patients, who preferred apps with user-friendly designs, educational content, and features that promote engagement in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of the Most Suitable App to Support the Self-Management of Hypertension: Systematic Selection Approach and Qualitative Study. Alessa, T., Hawley, M., de Witte, L.[2022]

A health belief model-based health education intervention significantly reduced systolic blood pressure by 7.37 mmHg and diastolic blood pressure by 4.07 mmHg in newly diagnosed hypertensive patients, demonstrating its efficacy in community settings.

The intervention improved patients' health beliefs, notably increasing perceived barriers and decreasing perceived seriousness, which were linked to better blood pressure control, highlighting the importance of psychological factors in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness evaluation of health belief model-based health education intervention for patients with hypertension in community settings]. Shen, Y., Wang, TT., Gao, M., et al.[2020]

The Smart Hypertension Control Study is a randomized controlled trial involving 350 adults with uncontrolled hypertension, aiming to assess the effectiveness of a smartphone application that provides personalized coaching for hypertension management alongside home blood pressure monitoring.

The primary outcome of the study is to evaluate changes in systolic blood pressure after six months, with additional outcomes focusing on medication adherence and self-management practices, which could enhance hypertension control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a randomized controlled trial comparing a mobile phone-based hypertension health coaching application to home blood pressure monitoring alone: The Smart Hypertension Control Study. Persell, SD., Karmali, KN., Stein, N., et al.[2019]

Nurse-led multimodal interventions significantly improved medication adherence, knowledge about hypertension, and self-efficacy among elderly patients over a 6-month period, indicating the effectiveness of these strategies in managing hypertension.

Despite improvements in adherence and knowledge, the study found no significant reductions in blood pressure levels or overall quality of life, suggesting that while the interventions were beneficial for adherence, they did not translate into immediate clinical outcomes in blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of multimodal interventions on medication nonadherence among elderly hypertensives: a randomized controlled study. Sheilini, M., Hande, HM., Prabhu, MM., et al.[2020]

The Tension Tamer (TT) app significantly reduced systolic blood pressure (SBP) in adults with stage 1 hypertension over 12 months, showing greater reductions compared to a lifestyle education program.

This study suggests that the TT app could be an effective and scalable first-line treatment for managing stage 1 hypertension, as evidenced by significant SBP reductions at 3, 6, and 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of 12-Month Smartphone Breathing Meditation Program upon Systolic Blood Pressure among Non-Medicated Stage 1 Hypertensive Adults. Chandler, J., Sox, L., Diaz, V., et al.[2020]

A study evaluated 4 DASH (Dietary Approaches to Stop Hypertension) apps, finding that only one paid app scored high in quality, while the free apps generally had lower quality ratings.

The research highlights the need for better development of free DASH apps, as the current options may not effectively support users in managing hypertension through diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. DiFilippo, KN., Huang, WD., Chapman-Novakofski, KM.[2020]

A systematic evaluation of seven DASH diet apps revealed that only two apps, NOOM and DASH To TEN, met both quality and data security standards, making them suitable for supporting self-management of the DASH diet.

While three apps scored high in quality across various domains, most apps exhibited significant shortcomings in quality and data privacy, highlighting the need for better app development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of the Most Suitable Mobile Apps to Support Dietary Approaches to Stop Hypertension (DASH) Diet Self-Management: Systematic Search of App Stores and Content Analysis. Alnooh, G., Alessa, T., Noorwali, E., et al.[2023]

Out of 948 blood pressure tracking apps screened, only 62 met the inclusion criteria, with an average quality score of 12.2 out of 28, indicating that most apps had variable quality and few adhered to best practices for home blood pressure monitoring.

Apps that included educational content or had a rating of 4 stars or higher demonstrated significantly better overall quality, suggesting that these features may enhance the effectiveness of BP tracking apps for self-management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Blood Pressure Tracking Apps for the iPhone: Content Analysis and Evaluation of Adherence With Home Blood Pressure Measurement Best Practices. Leong, AY., Makowsky, MJ.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337371/

mHealth Intervention for Promoting Hypertension Self ... [FAITH!] App) for promoting hypertension self-management among African American patients with uncontrolled hypertension (renamed as FAITH! Hypertension App).

2. withpower.com withpower.com/trial/phase-hypertension-3-2024-a0fb3

HTN App for High Blood Pressure The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN ...

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06346886

Study Details | NCT06346886 | HTN App for HTN Control ... The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self- ...

5. researchgate.net researchgate.net/publication/370374762_Mobile_Health_Intervention_to_Promote_Hypertension_Self-Management_among_African_Americans_Receiving_Care_at_a_Community_Health_Center_Formative_Evaluation_of_the_FAITH_Hypertension_App

Mobile Health Intervention to Promote Hypertension Self- ... These patients rated the intervention a 9 (out of 10) as helpful in hypertension self-management. Qualitative data revealed that these patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10867699/

Digital Health Interventions for Hypertension Management in ... These findings suggest that digital health interventions are associated with improved BP levels in populations experiencing health disparities.

7. jmir.org jmir.org/2025/1/e59841/

Trends and Gaps in Digital Precision Hypertension ... Objective: This scoping review aimed to fill a research gap in understanding the current state of precision health research using digital tools ...