Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II (vCCC 2)

University of Kansas

Status: Active, not recruiting

Conditions: Hypertension

Treatments: Other: Virtual Collaborative Care Clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT05138601

00147392

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

Usual Care with Education

No Intervention group

Description:

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)

Virtual Collaborative Care Clinic

Experimental group

Description:

Participants will partake in the virtual collaborative care clinic

Treatment:

Other: Virtual Collaborative Care Clinic