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Active, not recruitingNCT03612271mGlide RCTUpdated May 8, 2026

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

An interventional study of mGlide in Hypertension, sponsored by University of Minnesota. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
395
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • mHealth
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 395 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Stroke survivors (ischemic stroke or intra-parenchymal hemorrhage) or patients who have not had a stroke but carry a high risk of stroke or cardiovascular disease (CVD) events (>7.5% over 10 years) as defined by the AHA/ACC guideline on risk stratification9
  • Diagnosis of uncontrolled HTN at the time of study enrollment (need not have stroke)
  • Uncontrolled blood pressure (BP) defined as SBP > 150 mm Hg at the last 2 clinic visits in the 6 months prior to the screening date. Alternatively, if a patient was discharged from the hospital in the 6 months prior to screening and does not have 2 clinic visits after hospital discharge, at least one hospital SBP in the last 2 days of the hospital stay must be >150 mm Hg. Screening of uncontrolled HTN will be based on Electronic Medical Record (EMR) BP data.
  • Capable and willing to comply with the entire study protocol
  • Able to give voluntary written informed consent
  • English, Spanish or Hmong speaking
  • 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.)

Exclusion criteria

Exclusion Criteria:

  • Unable or unwilling to give consent
  • Any severe co-morbid illness including end stage kidney disease (ESRD), end stage liver disease (ESLD) or when life expectancy is less than 1 year or if primary care provider feels that medical complexity of the patient precludes clinical trial participation
  • Unable to complete study tasks
  • Any serious psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance including significant delusional disorders such as schizophrenia and bipolar illness.
  • Do not speak English, Spanish or Hmong
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
395 participants (actual)

Study arms

  • Experimental
    mGlide 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.

    Behavioral: mGlide

  • No intervention
    Clinical Care Comparison

    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.

Interventions

  • BehavioralmGlide

    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.

06

What researchers measure

Primary outcomes

  1. SBP

    Systolic Blood Pressure

    Time frame: 6 months

Secondary outcomes

  1. HTN Contol

    Alive and SBP \< 140 mmHg and Alive and SBP \< 130 mmHg

    Time frame: 6 months and 12 months

  2. Sustained BP control

    SBP

    Time frame: 12 months

Other outcomes

  1. Adverse events and side effects

    Adverse events and medication side effects

    Time frame: 6 months and 12 months

07

Study locations

1 site
  • Epidemiology Clinical Research Center
    Minneapolis, Minnesota 55415, United States
08

References and documents

Publications

  • Lakshminarayan K, Murray TA, Lunos S, McCarthy T, Everson-Rose SA, Overton V, Drawz PE, Streib C, Sakboonyarat B, Hatch H, Hibbard JH, Luepker RV, Connett J, Westberg SM. mHealth Intervention to Improve Hypertension Care in High-Risk Patients. Hypertension. 2026 Apr;83(4):e26148. doi: 10.1161/HYPERTENSIONAHA.125.26148. Epub 2026 Feb 20. PubMed 41717677 ↗
  • Northuis CA, Murray TA, Lutsey PL, Butler KR, Nguyen S, Palta P, Lakshminarayan K. Body mass index prediction rule for mid-upper arm circumference: the atherosclerosis risk in communities study. Blood Press Monit. 2022 Feb 1;27(1):50-54. doi: 10.1097/MBP.0000000000000567. PubMed 34534134 ↗
  • Lakshminarayan K, Murray TA, Westberg SM, Connett J, Overton V, Nyman JA, Culhane-Pera KA, Pergament SL, Drawz P, Vollbrecht E, Xiong T, Everson-Rose SA. Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 25;10(1):e25424. doi: 10.2196/25424. PubMed 33492231 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03612271
Lead sponsor
University of Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Aug 2, 2018
Start date
Mar 1, 2019
Primary completion
Aug 16, 2024
Completion
Apr 30, 2028 (estimated)
Last update
May 8, 2026

Study contacts

Kamakshi Lakshminarayan, MD, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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