mGlide-Care for High Blood Pressure

Overseen By Kamakshi Lakshminarayan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Severe comorbid illness, Active illicit drug use, Serious psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile health care model called mGlide-Care to help manage high blood pressure, particularly in individuals with mild memory problems like early Alzheimer's. The main goal is to determine if this mobile care is more effective than regular care in controlling blood pressure. Participants will either use mGlide-Care or continue with their usual care, and researchers will compare their progress. Suitable candidates have been diagnosed with early Alzheimer's or mild cognitive issues and have high blood pressure that isn't well-controlled. They also need a family member to assist them and must have a smartphone or tablet to track their health.

As an unphased trial, this study presents a unique opportunity to explore innovative care methods that could enhance health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that mGlide-Care is safe for hypertension management?

Research shows that the mGlide system is generally safe and easy to use. In earlier studies, people using mGlide were more likely to control their blood pressure compared to those receiving regular care, indicating effective management without major safety concerns.

The mGlide-Care model, a version of this system, targets individuals with high blood pressure and mild memory problems or early Alzheimer's. Although specific safety data for mGlide-Care is unavailable, the original mGlide system has not reported any serious safety issues. Participants use mobile technology to check their blood pressure at home, enhancing ease of use.

Overall, mGlide's success in controlling blood pressure without significant safety problems suggests that the mGlide-Care model is likely safe as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mGlide-Care model for high blood pressure because it offers a fresh approach to managing the condition. Unlike typical treatments that often rely on regular doctor visits for monitoring and medication adjustments, mGlide-Care integrates mobile health technology to enable self-monitoring and medication adjustments directly from home. This method aims to empower patients with more control over their treatment, potentially leading to better adherence and outcomes. By incorporating digital tools, it promises a more personalized and convenient way to keep blood pressure in check, which could revolutionize the way hypertension is managed.

What evidence suggests that mGlide-Care is effective for high blood pressure?

Research has shown that mGlide, a mobile health tool, helps people control high blood pressure. One study found that users were 60% more likely to manage their blood pressure than those receiving regular care. The program involves checking blood pressure at home and adjusting medication as needed. These methods have demonstrated promising results in effectively managing high blood pressure. In this trial, participants will be assigned to either the mGlide-Care model, based on this successful system, or to Usual Care Plus, which includes self-monitoring support. Early findings suggest that the mGlide-Care approach is both acceptable and practical for users, including those with early-stage cognitive issues like Alzheimer's. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with early-stage Alzheimer's or mild cognitive impairment who also have high blood pressure that isn't well-controlled. They need to have a family member willing to help, speak English, and both must be able to use a smartphone or similar device.

Inclusion Criteria

English speaking

Inclusion Criteria: Must meet all criteria

Have an unpaid, family caregiver

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development

Engage stakeholders to study the acceptability of mHealth mediated HTN care and use their input to develop mGlide-Care

Not specified

Feasibility Pilot

Test mGlide-Care vs. usual care in 75 participants with uncontrolled HTN and early stage AD/ADRD or MCI

6 months

Follow-up

Participants are monitored for HTN control and participant and caregiver reported measures

6 months

What Are the Treatments Tested in This Trial?

Interventions

• mGlide-Care
• Usual Care

Trial Overview

The study is testing mGlide-Care, an mHealth tool designed to manage high blood pressure in patients with cognitive impairments. It will compare the effectiveness of this new care model against usual care practices in a small group of participants.

How Is the Trial Designed?

Group I: mGlide-Care Experimental Treatment 1 Intervention

mHealth mediated HTN care model with self-monitoring and medication adjustment

Group II: Usual Care Plus Active Control 1 Intervention

Usual Care including self-monitoring support

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1.

ahajournals.org

ahajournals.org/doi/10.1161/hyp.81.suppl_1.26

Abstract 26: An Effective mHealth Intervention to Close the ...

The primary aim tested clinical effectiveness of mGlide in reducing SBP at 6 months. Secondary outcomes include resource utilization, adverse events and ...

2.

reporter.nih.gov

reporter.nih.gov/search/14E9CE024F8FC0D17598B8961CAA4A01A2FFCEB861BF/project-details/10400214

Project Details

Our results confirm excellent acceptability, high feasibility and promising efficacy of mGlide for achieving HTN control. Based upon this 4- month pilot we ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7870345/

Protocol for the mGlide Randomized Controlled Trial - PMC

Self-measured blood pressure monitoring (SMBP), an aspect of self-care, is effective in lowering blood pressure (BP) and improving HTN control [ ...

4.

withpower.com

withpower.com/trial/phase-hypertension-2-2019-43055

mGlide Mobile Health Intervention for High Blood Pressure

Research indicates that individuals using mGlide were 60% more likely to control their blood pressure compared to those receiving regular care. Specifically, ...

5.

trialx.com

trialx.com/clinical-trials/listings/281451/mglide-rct-a-clinical-glide-path-to-close-the-guideline-to-practice-gap-in-htn-management/?&radius=50&query=Health%20Care%20Team&smt=true

mGlide RCT: A Clinical Glide Path To Close the Guideline ...

Our intervention is called mGlide. Intervention participants will self- monitor their BP daily using a wireless BP monitor and a smart phone.

6.

researchprotocols.org

researchprotocols.org/2021/1/e25424/

Protocol for the mGlide Randomized Controlled Trial

This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to- ...

7.

scispace.com

scispace.com/pdf/mobile-health-intervention-to-close-the-guidelines-to-1fffr2x6l4.pdf

Mobile Health Intervention to Close the Guidelines-To- ...

A relatively simple mHealth intervention, mGlide, will monitor and transmit information on patients' blood pressure to their health care team. • ...

8.

sph.umn.edu

sph.umn.edu/research/projects/mglide/

mGlide - Research Projects and Studies

The mGlide study will teach you how to check your blood pressure at home. Checking blood pressure at home is better than measuring it one time at the clinic.