100 Participants Needed

HTN App for High Blood Pressure

LM
AK
Overseen ByAshton Krogman
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the FAITH HTN app treatment for high blood pressure?

Research shows that mobile apps can help people manage their high blood pressure by tracking their blood pressure and improving medication adherence. Apps that include health education and self-management tools have been shown to lower blood pressure in community settings.12345

Is the HTN App for High Blood Pressure safe for humans?

The available research does not provide specific safety data for the HTN App or its variants like FAITH! HTN app. However, it is important to note that many hypertension apps, in general, have not been validated against medical standards, and only a small percentage are developed by healthcare agencies.25678

How is the FAITH HTN app treatment different from other treatments for high blood pressure?

The FAITH HTN app is unique because it uses a smartphone application to help manage high blood pressure by providing health coaching and self-care guidance, which is different from traditional medication-based treatments. This app-based approach can be a scalable and accessible way to support lifestyle changes and improve blood pressure control.256910

What is the purpose of this trial?

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-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care.

Research Team

LB

LaPrincess C Brewer, MD, MPH

Principal Investigator

Mayo Clinic

Eligibility Criteria

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
See 7 more

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 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 GroupActive Control1 Intervention
African American adults with uncontrolled hypertension (HTN) will receive the standard of care of HTN management.

Find a Clinic Near You

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+

Findings from Research

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

References

Effect of Home Blood Pressure Monitoring via a Smartphone Hypertension Coaching Application or Tracking Application on Adults With Uncontrolled Hypertension: A Randomized Clinical Trial. [2020]
A content analysis of smartphone-based applications for hypertension management. [2022]
[Effectiveness evaluation of health belief model-based health education intervention for patients with hypertension in community settings]. [2020]
Impact of multimodal interventions on medication nonadherence among elderly hypertensives: a randomized controlled study. [2020]
Quality of Blood Pressure Tracking Apps for the iPhone: Content Analysis and Evaluation of Adherence With Home Blood Pressure Measurement Best Practices. [2020]
Impact of 12-Month Smartphone Breathing Meditation Program upon Systolic Blood Pressure among Non-Medicated Stage 1 Hypertensive Adults. [2020]
Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. [2020]
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. [2023]
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. [2019]
Identification of the Most Suitable App to Support the Self-Management of Hypertension: Systematic Selection Approach and Qualitative Study. [2022]
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