mGlide Mobile Health Intervention for High Blood Pressure

(mGlide RCT Trial)

Overseen By Emily Vollbrecht

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: End stage kidney, liver disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mobile health technology can help people manage high blood pressure (hypertension) more effectively. Participants will use a wireless blood pressure monitor and a smartphone to track their readings daily, with data sent directly to their healthcare team. The trial aims to improve blood pressure control, especially among stroke survivors and those at high risk for stroke or heart problems. It seeks individuals with uncontrolled high blood pressure, particularly those struggling to manage it despite treatment. Participants should have a smartphone or similar device to transmit their blood pressure readings. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance hypertension management for many.

Do I need to stop my current medications for the mGlide trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the mGlide mobile health intervention is safe for managing high blood pressure?

Studies have shown that the mGlide intervention is generally well-tolerated. In one study, participants using mobile health tools like mGlide reduced the top number of their blood pressure reading by 7.17 mm Hg more than those not using the tool. This suggests that mGlide effectively manages high blood pressure without causing significant problems.

Another study found that people using mGlide were 60% more likely to control their high blood pressure. Although one death was reported in the study, detailed safety information remains limited. However, as a mobile health technology, mGlide is non-invasive and involves self-monitoring, which typically carries a low risk of side effects.

Overall, evidence suggests mGlide is a safe option for managing high blood pressure, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mGlide intervention for high blood pressure because it leverages mobile health technology to empower patients in managing their condition. Unlike traditional methods that rely solely on clinic visits for blood pressure monitoring, mGlide enables patients to self-monitor their blood pressure and transmit the data in real-time. This allows for timely adjustments to anti-hypertensive medications, potentially leading to more personalized and effective management of high blood pressure. Additionally, by integrating technology with healthcare, mGlide could enhance patient engagement and adherence, ultimately improving health outcomes.

What evidence suggests that the mGlide intervention is effective for high blood pressure?

Studies have shown that the mGlide mobile health tool, which participants in this trial may receive, can significantly aid in managing high blood pressure. Research indicates that individuals using mGlide were 60% more likely to control their blood pressure compared to those receiving regular care. Specifically, participants using tools like mGlide experienced a reduction of about 7.17 points in their top blood pressure number. This suggests that mGlide could effectively manage high blood pressure, particularly for those at risk of stroke and heart disease. ^{1 2 4 6 7}

Who Is on the Research Team?

Kamakshi Lakshminarayan, MD, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults with uncontrolled high blood pressure, especially those at high risk of stroke or heart disease. Participants must speak English, Spanish, or Hmong and be able to use a smartphone compatible with the BP monitoring app. Stroke survivors are also eligible. People with severe illnesses like end-stage kidney/liver disease or serious psychiatric conditions cannot join.

Inclusion Criteria

Able to give voluntary written informed consent

Have a smart phone or mobile technology device (e.g. ipad) that can transmit BP from the BP monitor. iOS and Android Compatible. (iOS 7 or higher: iPhone 4 or higher, iPod touch 5th generation or higher, iPad 2nd generation or higher. Android 4.0 or higher.)

I have high blood pressure that isn't well-controlled.

Exclusion Criteria

I do not have severe kidney, liver disease, or any condition that limits my life to under a year.

Unable or unwilling to give consent

I am unable to perform tasks required by the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use mHealth technology to self-monitor blood pressure and adjust medications as needed

12 months

Weekly alerts for healthcare team

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• mGlide

Trial Overview The mGlide RCT tests if using mobile health technology can better manage high blood pressure in patients at risk of cardiovascular diseases. It involves daily self-monitoring of BP via a wireless monitor and smartphone, alerting healthcare teams when readings deviate from expected levels.

How Is the Trial Designed?

Group I: mGlide Intervention Experimental Treatment 1 Intervention

Participants will be educated on HTN and taught to self-monitor their BP. The transmitted BP will be used for adjustment of anti-HTN medications as it occurs in clinical practice.

Group II: Clinical Care Comparison Active Control 1 Intervention

Patients will be educated similar to intervention and taught self-monitoring of BP. Then they will be asked to follow up with primary care as usual.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7870345/

Protocol for the mGlide Randomized Controlled Trial - PMC This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to- ...

2. ahajournals.org ahajournals.org/doi/10.1161/hyp.81.suppl_1.26

Abstract 26: An Effective mHealth Intervention to Close the ... The odds of HTN control defined as “alive and SBP < 130 mm Hg”, was 60% higher in the mGlide arm (OR 1.6; 95% CI 1.03-2.48; p=0.035). There was one death in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03612271

mGlide RCT: A Clinical Glide Path To Close the Guideline ... In this study, the investigators demonstrate how mHealth (mobile health technology) can improve HTN control rates in stroke survivors and primary care patients ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748925002354

Effectiveness of mobile health interventions on physical ... Compared to the control group, participants receiving mobile health interventions showed greater decreases in systolic blood pressure by 7.17 mm ...

5. trialx.com trialx.com/clinical-trials/listings/281451/mglide-rct-a-clinical-glide-path-to-close-the-guideline-to-practice-gap-in-htn-management/?&radius=50&query=Health%20Care%20Team&smt=true

mGlide RCT: A Clinical Glide Path To Close the Guideline ... In this study, the investigators demonstrate how mHealth (mobile health technology) can improve HTN control rates in stroke survivors and ...

6. researchprotocols.org researchprotocols.org/2021/1/e25424/

Protocol for the mGlide Randomized Controlled Trial This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to- ...

7. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1049396/full

Effectiveness of a mHealth intervention on hypertension ... After 12 weeks of follow-up, the mean (SD) hypertension compliance increased by 7.35 (7.31) in the intervention group and by 3.01 (4.92) in the ...