NCT03612271

mGlide RCT: A Clinical Glide Path To Close the Guideline-to-Practice Gap In HTN Management

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Aim 1 will examine how well HTN is controlled in the two groups at 6 months and 12 months after randomization. Aim 2 will examine mGlide usability for providers and provider experience and satisfaction with mGlide. It will also examine whether medications are managed differently for participants in the two groups. Aim 3 will examine whether patients are more satisfied with care in the mGlide group, whether they are more "activated" and have a greater sense of self-efficacy in managing their HTN.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	mGlide	BP will be automatically transmitted to the providers. The transmitted BP will be used for adjustment of anti-HTN medications as it occurs in clinical practice.

Timeline

• Start date: 2019-03-01
• Primary completion: 2024-08-16
• Completion: 2026-04-30
• First posted: 2018-08-02
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States