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NCT Number: NCT05850416

mGlide-Care: A Partnership With Caregivers

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.

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Key information

Conditions

HTN

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Epidemiology Clinical Research Center

Minneapolis, Minnesota, 55415, United States

Location status: Recruiting

Location contact

Research Coordinator

CONTACT

[email protected]

612-626-7979

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mGlide-Care

Other

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

Usual Care +

Other

Usual Care with self-monitoring support

Primary outcomes

  1. HTN control

    Time frame: 6 months and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kamakshi Lakshminarayan

CONTACT

[email protected]

6512085980

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 9, 2023
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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