mGlide-Care: A Partnership With Caregivers

mGlide-Care: A Partnership With Caregivers to Improve HTN Management in Patients With Cognitive Impairment

Hypertension (HTN) is the most significant stroke, cardiovascular disease and dementia risk factor and is substantially under-treated especially in older persons. In this study the investigators will develop mGlide-Care to address uncontrolled HTN in people with mild cognitive impairment (MCI) and early stage Alzheimer's Disease and Alzheimer's Disease Related Dementia (AD/ADRD). mGlide-Care is adapted from mGlide which is a mHealth (mobile health technology) mediated care model for HTN care. Aim 1 will engage stakeholders to study the acceptability of mHealth mediated HTN care and will use their input to develop mGlide-Care. Stakeholders are persons with early stage AD/ADRD and MCI, unpaid family caregivers, primary care providers, geriatricians and clinical pharmacists. Aim 2 is a feasibility pilot to test mGlide-Care vs. usual care in 75 participants with uncontrolled HTN and early stage AD/ADRD or MCI. Caregivers will assist participants. Outcomes will include HTN control and participant and caregiver reported measures.

Study Overview

• Status: Recruiting
• Conditions: HTN
• Intervention / Treatment: Other: mGlide-Care; Other: Usual Care +

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamakshi Lakshminarayan; Phone Number: 6512085980; Email: mGlideCare@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • Epidemiology Clinical Research Center
      • Contact: Research Coordinator; Phone Number: 612-626-7979; Email: mGlideCare@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Must meet all criteria

• Diagnosed with early stage AD/ADRD or MCI
• Have uncontrolled hypertension (HTN)
• Have an unpaid, family caregiver
• Have established medical diagnosis of hypertension (HTN)
• English speaking
• Participant or caregiver must have a smartphone or mobile device (e.g. iPad) that can transmit blood pressure (BP) from the BP monitor
• Participant and caregiver capable and willing to comply with the entire study protocol
• Able to give voluntary written informed consent.

Exclusion Criteria: Any of the following will be an exclusion.

• Severe comorbid illness including end-stage kidney disease, end-stage liver disease, and life expectancy <1 year, or if medical complexity of the patient precludes clinical trial participation
• Active illicit drug use (e.g. cocaine, methamphetamines, opioids, phencyclidine) since this will interfere with HTN management
• Participant and caregiver unable to complete study tasks, including are homeless, will leave the country, or will relocate in the next 12 months
• Serious psychiatric illness that could interfere with treatment, assessment, or compliance including significant delusional disorders such as schizophrenia and bipolar illness
• Unable or unwilling to give consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mGlide-Care; mHealth mediated HTN care model with self-monitoring and medication adjustment	Other: mGlide-Care; Mhealth mediated model of HTN care with self-monitoring and medication management
Active Comparator: Usual Care Plus; Usual Care including self-monitoring support	Other: Usual Care +; Usual Care with self-monitoring support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HTN control	HTN control rates in intervention vs. control arm participants. HTN control for each participant will be defined based on personalized threshold for participant as determined by primary care.	6 months and 12 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00017458; 5K24AG078506 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No