395 Participants Needed

mGlide Mobile Health Intervention for High Blood Pressure

EV
Overseen ByEmily Vollbrecht
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Hypertension (HTN) is the most important stroke and cardiovascular disease (CVD) risk factor. Unfortunately, there is substantial under-treatment of HTN. Of the 86 million adults with prevalent HTN in the U.S., 40 million (46%) have inadequately controlled blood pressure (BP). This problem is worse among minority groups. In this study, the investigators demonstrate how mHealth (mobile health technology) can improve HTN control rates in stroke survivors and primary care patients without stroke, but who are at a high risk of stroke and CVD. Our intervention is called mGlide. Intervention participants will self- monitor their BP daily using a wireless BP monitor and a smart phone. The phone will transmit this BP to a database automatically. The investigators will use the framework of glide paths to manage the transmitted BP data. The glide path, based on the concept of landing an airplane, establishes an expected trajectory of BP readings for each patient with bounds set by guidelines and provider input. BP is monitored at home; the health care team is alerted when patient BP deviates from expected bounds. Alerts are generated once a week for the health care team with a list of patients with uncontrolled HTN. This facilitates early intervention while avoiding information overload. Partnering clinical centers include Federally Qualified Health Centers that serve low income and minority (Latino, African American, Hmong) communities. In this RCT study, the investigators will randomize 450 participants with uncontrolled HTN to the mGlide intervention (n=225) vs. state-of-clinical-care comparison (n=225).

Research Team

KL

Kamakshi Lakshminarayan, MD, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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.
I am willing and able to follow all study requirements.
See 3 more

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: mGlide InterventionExperimental Treatment1 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 ComparisonActive Control1 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.

Find a Clinic Near You

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+
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