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mGlide-Care: A Partnership With Caregivers

Sponsor
University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05850416
Collaborator
(none)
75
Enrollment
2
Arms
57
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mGlide-Care
  • Other: Usual Care +
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
mGlide-Care: A Partnership With Caregivers to Improve HTN Management in Patients With Cognitive Impairment
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Mar 30, 2027
Anticipated Study Completion Date :
Mar 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: mGlide-Care

mHealth mediated HTN care model with self-monitoring and medication adjustment

Other: mGlide-Care
Mhealth mediated model of HTN care with self-monitoring and medication management
Active Comparator: Usual Care Plus

Usual Care including self-monitoring support

Other: Usual Care +
Usual Care with self-monitoring support

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05850416
Other Study ID Numbers:
  • STUDY00017458
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 9, 2023