mGlide-Care: Partnering with Caregivers to Manage High Blood Pressure
mGlide-Care: A Partnership With Caregivers to Improve HTN Management in Patients With Cognitive Impairment
NA · University of Minnesota · NCT05850416
This project will test a smartphone-based blood pressure program, mGlide-Care, to help people with mild cognitive impairment or early Alzheimer's disease and their unpaid family caregivers improve control of high blood pressure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05850416 on ClinicalTrials.gov |
What this trial studies
mGlide-Care adapts an existing mHealth hypertension care model to the needs of people with early-stage AD/ADRD or MCI by explicitly involving unpaid family caregivers in home blood pressure monitoring and communication with clinical teams. In Aim 1 investigators will engage patients, caregivers, primary care providers, geriatricians, and pharmacists to refine the intervention for acceptability and usability. In Aim 2 they will run a feasibility pilot comparing mGlide-Care to usual care in 75 participants with uncontrolled hypertension, with caregivers assisting participants in using smartphone-connected BP monitors. Primary outcomes include feasibility measures and blood pressure control, collected through remote BP transmissions and routine clinical follow-up at the Minneapolis site.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults with early-stage AD/ADRD or MCI who have uncontrolled hypertension, an established HTN diagnosis, an unpaid family caregiver willing to assist, and access to a smartphone or tablet that can transmit blood pressure readings.
Not a fit: Patients with severe life-limiting comorbid illness, active illicit drug use, homelessness or inability to complete study tasks, or those without a caregiver or compatible mobile device are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, mGlide-Care could help people with early AD/MCI and their caregivers achieve better blood pressure control, which may lower risk of stroke and heart disease.
How similar studies have performed: mGlide-Care is adapted from mGlide, and mobile health programs have improved blood pressure control in other populations, but caregiver-mediated HTN management specifically in early AD/ADRD is largely untested.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Minneapolis, Minnesota
- Epidemiology Clinical Research Center — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Study coordinator: Kamakshi Lakshminarayan
- Email: mGlideCare@umn.edu
- Phone: 6512085980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HTN