Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II

NCT ID: NCT05138601

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2026-12-31

Brief Summary

This is a randomized, controlled, pragmatic trial designed as a "type I hybrid effectiveness-implementation trial" that tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems.

Detailed Description

This study tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems (University of Kansas Health System [UKHS] and the University of Utah Health [UUtah]). The vCCC is staffed by clinical pharmacists who remotely monitor home BP and use telehealth to work with patients to lower systolic blood pressure (SBP) to <130 mmHg, as recommended by the current American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Eligible patients with uncontrolled hypertension (HTN) are identified automatically through the electronic health record (EHR) during visits to their Primary Care Provider (PCP) and referred for enrollment into the vCCC.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual Care with Education

The participant will be provided with educational material and a home BP monitor. Control participants will continue to see their physicians for their usual care for BP management (their BP data will not be reviewed by pharmacists and the patients will not have support from vCCC pharmacists)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Virtual Collaborative Care Clinic

Participants will partake in the virtual collaborative care clinic

Group Type: EXPERIMENTAL

Virtual Collaborative Care Clinic

Intervention Type: OTHER

Trained clinical pharmacists will monitor BP, prescribe and adjust medications and monitor for side effects of medications under the license of, and in communication with, the patient's physician.

Interventions

Virtual Collaborative Care Clinic

Trained clinical pharmacists will monitor BP, prescribe and adjust medications and monitor for side effects of medications under the license of, and in communication with, the patient's physician.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 65 and older
• Active patient in participating primary care clinic
• Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network)
• Elevated BP as defined by
• SBP >140 at current visit AND documented history of hypertension OR SBP > 140 at current visit and at another visit in last 18 months OR SBP >160 at current visit
• Sufficiently fluent in English to participate in study procedures
• Adequate hearing to complete study procedures
• Able to give their own signed consent
• Health insurance coverage by Medicare

Exclusion Criteria

• Clinically significant illness that may affect safety or completion per their treating PCP or study physician
• Needing interpreter for clinic visits (through Electronic Health Record)
• Currently in hospice care
• Currently receiving chemotherapy
• Unable to take accurate BP measurement, either due to inability to follow protocol to check BP or due to medical conditions such as lymphedema or dialysis access on both arms.
• Currently participating in another intervention trial
• End stage kidney disease on dialysis
• Diagnosis of dementia (i.e., dementia, Alzheimer's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia)
• Chronic active disease with expected life expectancy < 2 years as determined by the study team

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Burns, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Health System

Kansas City, Kansas, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00147392

Identifier Type: -

Identifier Source: org_study_id