mGlide-Care: A Partnership With Caregivers

HTN Clinical Trial

Official title:

mGlide-Care: A Partnership With Caregivers to Improve HTN Management in Patients With Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05850416
• Other study ID #: STUDY00017458
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: May 30, 2028

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: May 30, 2028
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• HTN

Intervention

Other:
• mGlide-Care
Mhealth mediated model of HTN care with self-monitoring and medication management
• Usual Care +
Usual Care with self-monitoring support

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HTN control	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.	6 months and 12 months