mGlide-Care: A Partnership With Caregivers

NCT ID: NCT05850416

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2028-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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HTN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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mGlide-Care

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

Group Type EXPERIMENTAL

mGlide-Care

Intervention Type OTHER

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

Usual Care Plus

Usual Care including self-monitoring support

Group Type ACTIVE_COMPARATOR

Usual Care +

Intervention Type OTHER

Usual Care with self-monitoring support

Interventions

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mGlide-Care

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

Intervention Type OTHER

Usual Care +

Usual Care with self-monitoring support

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

* 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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Epidemiology Clinical Research Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kamakshi Lakshminarayan

Role: CONTACT

Phone: 6512085980

Email: [email protected]

Facility Contacts

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Research Coordinator

Role: primary

Other Identifiers

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5K24AG078506

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00017458

Identifier Type: -

Identifier Source: org_study_id