Clinical trial NCT05138601: Remote Monitoring and Virtual Collaborative Care for Hypertension Control to Prevent Cognitive Decline Phase II
Official title: Remote Monitoring and Virtual Collaborative Care for Hypertension Control to Prevent Cognitive Decline Phase II
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Utah
name: University of Missouri-Columbia
First posted: 2021-12-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Systolic Blood Pressure (SBP) Control At 24 Months
timeFrame: 24 months.
Secondary outcomes:
measure: Cognitive Measures
timeFrame: 0 months, 12 months, and 24 months
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 24 months
measure: Atherosclerotic Cardiovascular Disease Risk (ASCVD)
timeFrame: 24 months
measure: Health Care Resource Utilization: Charges Per Patient
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
measure: Systolic Blood Pressure (SBP) Control At 12 Months
timeFrame: 12 Months
measure: Health utilization outcome measurement: Carrier Claims
timeFrame: 2 years
measure: Health utilization outcome measurement: facility claims
timeFrame: 2 years
measure: Health utilization outcome measurement: coronary care claims
timeFrame: 2 years
measure: Health utilization outcome measurement: coronary care expenditures
timeFrame: 2 years
measure: Health utilization outcome measurement: coronary care unit days
timeFrame: 2 years
measure: Health utilization outcome measurement: intensive care unit (ICU) days
timeFrame: 2 years
measure: Health utilization outcome measurement: general drug claims
timeFrame: 2 years
measure: Health utilization outcome measurement: durable medical equipment Medicare payments
timeFrame: 2 years
measure: Health utilization outcome measurement: imaging and laboratory events
timeFrame: 2 years
measure: Health utilization outcome measurement: imaging and laboratory expenditures
timeFrame: 2 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Burns, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: