NCT05850416

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026May 2028

First Submitted

Initial submission to the registry

March 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

March 24, 2023

Last Update Submit

February 10, 2026

Conditions

HTN

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

mGlide-Care

EXPERIMENTAL

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

Other: mGlide-Care

Usual Care Plus

ACTIVE COMPARATOR

Usual Care including self-monitoring support

Other: Usual Care +

Interventions

mGlide-CareOTHER

Mhealth mediated model of HTN care with self-monitoring and medication management

mGlide-Care
Usual Care +OTHER

Usual Care with self-monitoring support

Usual Care Plus

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epidemiology Clinical Research Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Central Study Contacts

Kamakshi Lakshminarayan

CONTACT

6512085980mGlideCare@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

May 9, 2023

Study Start

January 15, 2026

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

US(1)