NCT05850416 · University of Minnesota
mGlide-Care: A Partnership With Caregivers
What this study is 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).
View original scientific description
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.
Interventions
OTHER
mGlide-Care
Mhealth mediated model of HTN care with self-monitoring and medication management
OTHER
Usual Care +
Usual Care with self-monitoring support
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Minneapolis, Minnesota
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations