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

NCT03612271 | Active Not Recruiting DMC

• 3 other identifiers: SPH-2022-270341R01HL138332-01A1STUDY00003494
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hypertension

Keywords

Hypertension; mHealth

Outcome Measures

Primary Outcomes (1)

• SBP

  Systolic Blood Pressure

  6 months

Secondary Outcomes (2)

• HTN Contol

  6 months and 12 months

• Sustained BP control

  12 months

Other Outcomes (1)

• Adverse events and side effects

  6 months and 12 months

Study Arms (2)

mGlide Intervention

EXPERIMENTAL

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

Clinical Care Comparison

NO 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.

Interventions

mGlide BEHAVIORAL

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.

mGlide Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Epidemiology Clinical Research Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (3)

• 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.

  PMID: 41717677 DERIVED

• 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.

  PMID: 34534134 DERIVED

• 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.

  PMID: 33492231 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kamakshi Lakshminarayan, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The PI does not have any access to outcomes until unblinding. The BP outcomes are collected by a blinded research staff.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: March 1, 2019
• Primary Completion: August 16, 2024
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)