mGlide-Care: A Partnership With Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mGlide-Care, Usual Care +.
- Who it may be relevant to
- Registry conditions: HTN. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
mGlide-Care: A Partnership With Caregivers to Improve HTN Management in Patients With Cognitive Impairment
Overview
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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Epidemiology Clinical Research Center — Minneapolis
Identifiers
NCT: NCT05850416 · STUDY00017458 · 5K24AG078506