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

Primary Purpose

Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mGlide

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, mHealth

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 >140 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 >140 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

Sites / Locations

Epidemiology Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mGlide Intervention

Clinical Care Comparison

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HTN control into guideline specified range

(SBP <140 mm Hg)

Secondary Outcome Measures

Full Information

NCT ID

NCT03612271

First Posted

July 26, 2018

Last Updated

February 7, 2023

Sponsor

University of Minnesota

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03612271

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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. Aim 4 will be a cost-effectiveness analysis of providing mGlide care. The long-term goal is to prevent stroke and improve cardiovascular health in populations by increasing health system efficiency and effectiveness. The results from our mGlide RCT will provide evidence for the use of readily available mHealth technology for bridging the guideline-to-practice gap in HTN treatment in low resource health systems serving minority groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Hypertension, mHealth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mGlide Intervention

Arm Type

Experimental

Arm Description

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.

Arm Title

Clinical Care Comparison

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

mGlide

Intervention Description

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.

Primary Outcome Measure Information:

Title

HTN control into guideline specified range

Description

(SBP <140 mm Hg)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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 >140 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 >140 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emily Vollbrecht

Phone

612-626-7979

vollb007@umn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kamakshi Lakshminarayan, MD, PhD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

Epidemiology Clinical Research Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emily Vollbrecht

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34534134

Citation

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.

Results Reference

derived

PubMed Identifier

33492231

Citation

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.

Results Reference

derived

Learn more about this trial

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

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