HypertensionmGlide RCTNCT03612271
mGlide RCT: A Clinical Glide Path To Close the Guideline-to-Practice Gap In HTN Management
A study testing mGlide in people with Hypertension, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- mGlide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Epidemiology Clinical Research Center
Minneapolis, Minnesota, 55415
About this study
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.
- Conditions
- Hypertension
- Being tested
- mGlide
- Keywords
- Hypertension, mHealth
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mGlideBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBP
Systolic Blood Pressure
Measured: 6 months
Secondary outcomes (2)
HTN Contol
Alive and SBP < 140 mmHg and Alive and SBP < 130 mmHg
Measured: 6 months and 12 months
Sustained BP control
SBP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Mar 2019
- Primary completion16 Aug 2024
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kamakshi Lakshminarayan, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612271
- Sponsor's protocol ID
- SPH-2022-27034
- Other IDs
- 1R01HL138332-01A1, STUDY00003494
- Acronym
- mGlide RCT
- Status last verified
- May 2026
- First submitted
- 26 Jul 2018
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 41717677Northuis 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 34534134Lakshminarayan 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mGlide RCT: A Clinical Glide Path To Close the Guideline-to-Practice Gap In HTN Management
- ClinicalTrials.gov ID
- NCT03612271
- Acronym / sponsor ID
- mGlide RCT / SPH-2022-27034
- Conditions
- Hypertension
- Keywords
- Hypertension, mHealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 395 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mGlide Intervention | Experimental | Behavioral: mGlideParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mGlideBP 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. | Behavioural | mGlide Intervention |
Primary outcome
SBP
Time frame: 6 months
Systolic Blood Pressure
2 secondary outcomes
HTN Contol
Time frame: 6 months and 12 months
Sustained BP control
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 41717677Lakshminarayan 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.
- Derived from this study: PubMed 34534134Northuis 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.
- Derived from this study: PubMed 33492231Lakshminarayan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamakshi Lakshminarayan, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mGlide in people with Hypertension, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SBP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612271, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.