Mobile App for Sodium Management for High Blood Pressure

Overseen By Sabah Ganai

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Antihypertensives

Disqualifiers: Unstable BP, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This research is being done to learn if a smartphone app with and without a just in time adaptive intervention (JITAI) can help patients with hypertension manage their sodium intake and improve their blood pressure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have been on stable doses of your blood pressure medication for at least three months before joining.

What data supports the effectiveness of the LowSalt4Life App treatment for managing high blood pressure?

Research shows that mobile apps can help people manage high blood pressure by improving self-management and encouraging lifestyle changes like reducing sodium intake. Apps like SaltSwitch have been effective in helping users choose lower-salt food options, which can lead to modest reductions in blood pressure. ^{1 2 3 4 5}

Is the Mobile App for Sodium Management safe for humans?

The available research on mobile apps for managing high blood pressure, including those for sodium reduction, suggests they are generally safe for human use. These apps have been used in studies to help manage blood pressure and improve lifestyle habits without reported safety concerns. ^{1 2 3 5 6}

How is the LowSalt4Life App treatment different from other treatments for high blood pressure?

The LowSalt4Life App is unique because it uses a mobile application to help manage sodium intake, which is a key factor in controlling high blood pressure. Unlike traditional treatments that may focus on medication, this app provides a digital tool for self-management, potentially improving adherence to a low-sodium diet through technology. ^{1 2 3 5 7}

Research Team

Brahmajee K Nallamothu, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for English-speaking adults with stable high blood pressure, who've been on the same hypertension meds for at least three months. They must own a smartphone compatible with the LowSalt4Life app and be willing to receive notifications. People with unstable blood pressure, secondary causes of hypertension, heart failure, certain kidney issues or those pregnant can't participate.

Inclusion Criteria

Owns a smartphone with a compatible Apple or Android operating system installed and able to download and use LowSalt4Life app including accepting all permissions and willing to allow the mobile applications to send push notifications

I have a smartphone that can download and use the LowSalt4Life app.

Fluent in spoken and written English

Exclusion Criteria

I do not have conditions like adrenal insufficiency or pheochromocytoma causing my high blood pressure.

I have heart failure.

Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the LowSalt4Life app with or without JITAI for sodium intake and blood pressure management

2 months

Virtual interactions via app

Micro-randomized trial (MRT)

MRT conducted within the App+JITAI group to evaluate push notification effectiveness

2 months

Exploratory Data Collection

Participants continue app usage for additional data collection on exploratory measures

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Just-In-time Adaptive Intervention (JITAI)
• LowSalt4Life Application

Trial Overview The study tests if a mobile app called LowSalt4Life can help manage sodium intake and lower blood pressure in hypertensive patients. It will compare the effectiveness of the app alone versus the app combined with JITAI (just-in-time adaptive intervention).

Participant Groups

Group I: LowSalt4Life + just-in-time adaptive intervention (JITAI) Experimental Treatment 2 Interventions

Group II: LowSalt4Life Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

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]

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]

Smartphone applications can significantly enhance the management of hypertension by improving medication adherence, blood pressure control, and promoting lifestyle changes, especially among younger users.

While technology interventions show promise in reducing physical inactivity and obesity, further research is needed to identify the most effective components of these interventions and to make them more accessible for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile applications and management of hypertension: possibilities, problems and perspectives]. Becker, S., Mitchell, A., Königsmann, T., et al.[2021]

The DASH Mobile system is designed to help hypertensive patients adopt the DASH diet, which emphasizes fruits, vegetables, low-fat dairy, and lean protein, while also promoting physical activity and reducing sodium intake.

This mobile health (mHealth) app aims to make it easier for users to track their diet and health metrics, potentially overcoming the challenges of traditional in-person interventions and improving patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. Mann, DM., Kudesia, V., Reddy, S., et al.[2013]

A 12-week trial using the SaltSwitch app and reduced-sodium salts (RSS) did not show a significant reduction in dietary sodium intake among adults with high blood pressure, indicating that the intervention may not have been effective.

Despite most participants reporting usage of the SaltSwitch app and RSS, challenges related to engagement and the COVID-19 pandemic may have limited the study's power to detect a true effect on sodium reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Sodium-Reduction Smartphone App and Reduced-Sodium Salt to Lower Sodium Intake in Adults With Hypertension: Findings From the Salt Alternatives Randomized Controlled Trial. Eyles, H., Grey, J., Jiang, Y., et al.[2023]

The HERB-Digital Hypertension 1 trial demonstrated that a hypertension treatment app significantly reduced blood pressure in patients, showing better results than traditional physician management alone.

This app received global approval in Japan in 2022, paving the way for its widespread use in managing hypertension, although further research is needed to identify which patients will benefit most and to establish guidelines for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice. Kario, K., Harada, N., Okura, A.[2022]

A randomized controlled trial involving 120 hypertensive patients showed that using a mobile health management application significantly reduced both systolic and diastolic blood pressure compared to conventional management methods over three months.

The experimental group not only experienced lower blood pressure but also improved self-management behaviors, as indicated by higher scores on the Hypertension Patients Self-Management Behavior Rating Scale after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effects of a new management mode for hypertensive patients: a randomized controlled trial. Sun, YQ., Jia, YP., Lv, JY., et al.[2022]

References

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

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. [2020]

2. United States 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. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

[Mobile applications and management of hypertension: possibilities, problems and perspectives]. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. [2013]

5. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of a Sodium-Reduction Smartphone App and Reduced-Sodium Salt to Lower Sodium Intake in Adults With Hypertension: Findings From the Salt Alternatives Randomized Controlled Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice. [2022]

7. China pubmed.ncbi.nlm.nih.gov

The clinical effects of a new management mode for hypertensive patients: a randomized controlled trial. [2022]