Recruiting

mGlide-Care

Sponsor:

University of Minnesota

Code:

NCT05850416

Conditions

HTN

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

mGlide-Care

Usual Care +

Study Details

Brief summary:

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.

Conditions

HTN

Study ID

NCT05850416

Start date

Jan 15, 2026

Status verified date

Feb, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mGlide-Care

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

active comparator: Usual Care Plus

Usual Care including self-monitoring support

Interventions

mGlide-Care

Mhealth mediated model of HTN care with self-monitoring and medication management

Usual Care +

Usual Care with self-monitoring support

Primary outcome measure

  • HTN control [ Time Frame: 6 months and 12 months ]

Central Contacts and Locations

Central contacts

Kamakshi Lakshminarayan

6512085980mGlideCare@umn.edu

Locations

Epidemiology Clinical Research Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Research Coordinator

612-626-7979mGlideCare@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-02-13.