mGlide-Care: A Partnership With Caregivers

University of Minnesota (UMN)

Status: Enrolling

Conditions: HTN

Treatments: Other: Usual Care +; Other: mGlide-Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05850416

5K24AG078506 (U.S. NIH Grant/Contract)

STUDY00017458

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

mGlide-Care

Experimental group

Description:

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

Treatment:

Other: mGlide-Care

Usual Care Plus

Active Comparator group

Description:

Usual Care including self-monitoring support

Treatment:

Other: Usual Care +