HTN
Conditions
Brief summary
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
OTHERmGlide-Care
Mhealth mediated model of HTN care with self-monitoring and medication management
OTHERUsual Care +
Usual Care with self-monitoring support
Sponsors
University of Minnesota
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HTN control | 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. |
Countries
United States
Contacts
CONTACTKamakshi Lakshminarayan
Outcome results
None listed