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mGlide Mobile Health Intervention for High Blood Pressure

N/A
Recruiting
Led By Kamakshi Lakshminarayan, MD, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of uncontrolled HTN at the time of study enrollment (need not have had a stroke)
Stroke survivors (ischemic stroke or intra-parenchymal hemorrhage) or patients at high risk of stroke or cardiovascular disease (CVD) events (>7.5% over 10 years)
Must not have
Any severe co-morbid illness including end stage kidney disease (ESRD), end stage liver disease (ESLD) or life expectancy 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial is testing whether a mobile health intervention can improve blood pressure control in stroke survivors and high-risk patients without stroke.

Who is the study for?
This trial is for adults with uncontrolled high blood pressure, especially those at high risk of stroke or heart disease. Participants must speak English, Spanish, or Hmong and be able to use a smartphone compatible with the BP monitoring app. Stroke survivors are also eligible. People with severe illnesses like end-stage kidney/liver disease or serious psychiatric conditions cannot join.
What is being tested?
The mGlide RCT tests if using mobile health technology can better manage high blood pressure in patients at risk of cardiovascular diseases. It involves daily self-monitoring of BP via a wireless monitor and smartphone, alerting healthcare teams when readings deviate from expected levels.
What are the potential side effects?
Since mGlide is a mobile health intervention focused on monitoring and managing blood pressure rather than a medication, it does not have direct side effects like drugs do. However, there may be indirect effects related to stress or anxiety from constant health monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have high blood pressure that isn't well-controlled.
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I have survived a stroke or am at high risk for stroke or heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe kidney, liver disease, or any condition that limits my life to under a year.
Select...
I am unable to perform tasks required by the study.
Select...
I speak English, Spanish, or Hmong.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HTN control into guideline specified range

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: mGlide InterventionExperimental Treatment1 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 II: Clinical Care ComparisonActive Control1 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.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,413 Previous Clinical Trials
1,560,953 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,833,757 Total Patients Enrolled
Kamakshi Lakshminarayan, MD, PhDPrincipal InvestigatorUniversity of Minnesota

Media Library

mGlide Clinical Trial Eligibility Overview. Trial Name: NCT03612271 — N/A
High Blood Pressure Research Study Groups: mGlide Intervention, Clinical Care Comparison
High Blood Pressure Clinical Trial 2023: mGlide Highlights & Side Effects. Trial Name: NCT03612271 — N/A
mGlide 2023 Treatment Timeline for Medical Study. Trial Name: NCT03612271 — N/A
~20 spots leftby Dec 2024
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