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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
No Placebo-Only Group
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 belowSelect...
I have high blood pressure that isn't well-controlled.
Select...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,252 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,791,881 Total Patients Enrolled
Kamakshi Lakshminarayan, MD, PhDPrincipal InvestigatorUniversity of Minnesota
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe kidney, liver disease, or any condition that limits my life to under a year.I have high blood pressure that isn't well-controlled.I am willing and able to follow all study requirements.I speak English, Spanish, or Hmong.I am unable to perform tasks required by the study.My blood pressure has been over 140 mm Hg recently.You have a serious mental illness, like schizophrenia or bipolar disorder, that could affect your ability to participate in the study.I speak English, Spanish, or Hmong.I have survived a stroke or am at high risk for stroke or heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: mGlide Intervention
- Group 2: Clinical Care Comparison
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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