Clinical trial NCT04585880: Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline
Official title: Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cognitive Decline
Keywords: Hypertension
Cognitive Decline
Mild Cognitive Decline
Memory Loss
Memory Disorders
Memory Impairment
Blood Pressure
Blood Pressure, High
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-10-14
Enrollment: 33
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 purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.


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)
* Elevated blood pressure as defined by:

Systolic Blood Pressure \>140 at current visit AND documented history of hypertension OR Systolic Blood Pressure \> 140 at current visit and at another visit in last 18 months OR Systolic Blood Pressure \>160 at current visit

* Sufficiently fluent in English to participate in study procedures
* Adequate vision and hearing to complete study procedures

Exclusion Criteria:

* Clinically significant illness that may affect safety or completion per their treating Primary Care Physician or study physician
* End stage renal disease on dialysis
* Chronic active disease with expected life expectancy \< 2 years as determined by the study team

Primary outcomes:
measure: Feasibility of system wide adoptability as assessed by survey responses
timeFrame: Baseline
measure: Feasibility of system wide adoptability as assessed by survey responses
timeFrame: 3 Months Post Baseline
measure: Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion
timeFrame: Through study completion, an average of 9 months
measure: Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews
timeFrame: Up to 2 months Post Baseline
measure: Replicability to other health systems as assessed by survey responses
timeFrame: Baseline
measure: Replicability to other health systems as assessed by survey responses
timeFrame: 3 Months Post Baseline
measure: Replicability to other health systems as assessed by Physician Advisory Board meetings discussion
timeFrame: Through study completion, an average of 9 months
measure: Replicability to other health systems as assessed by vCCC Pharmacist Interviews
timeFrame: Up to 2 months Post Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Burns, MD
role: PRINCIPAL_INVESTIGATOR
References: