What this study is
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.
What's being tested
- mGlide-Care
Intervention · OTHER
Mhealth mediated model of HTN care with self-monitoring and medication management
- Usual Care +
Intervention · OTHER
Usual Care with self-monitoring support
Study details
- Official title
- mGlide-Care: A Partnership With Caregivers to Improve HTN Management in Patients With Cognitive Impairment
- Sponsor
- University of Minnesota
- Conditions
- HTN
- Enrolling
- 75 people
- Starts
- 2026-01-15
- Est. completion
- 2028-05-30
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openEpidemiology Clinical Research Center
Minneapolis, Minnesota, United States
- Research Coordinator · Contact612-626-7979mGlideCare@umn.edu
Recruiting
Study team
Sponsor
University of Minnesota
Study ID STUDY00017458
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.