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

NCT ID: NCT03612271

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2026-04-30

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

mGlide

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kamakshi Lakshminarayan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Epidemiology Clinical Research Center

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34534134 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33492231 (View on PubMed)

Other Identifiers

1R01HL138332-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003494

Identifier Type: OTHER

Identifier Source: secondary_id

SPH-2022-27034

Identifier Type: -

Identifier Source: org_study_id