Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline

Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I

Sponsors

Lead Sponsor: University of Kansas Medical Center

Collaborator: National Institute on Aging (NIA)

Source University of Kansas Medical Center
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.

Overall Status Enrolling by invitation
Start Date October 20, 2020
Completion Date March 2021
Primary Completion Date March 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility of system wide adoptability as assessed by survey responses Baseline
Feasibility of system wide adoptability as assessed by survey responses 3 Months Post Baseline
Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion Through study completion, an average of 9 months
Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews Up to 2 months Post Baseline
Replicability to other health systems as assessed by survey responses Baseline
Replicability to other health systems as assessed by survey responses 3 Months Post Baseline
Replicability to other health systems as assessed by Physician Advisory Board meetings discussion Through study completion, an average of 9 months
Replicability to other health systems as assessed by vCCC Pharmacist Interviews Up to 2 months Post Baseline
Enrollment 60
Condition
Intervention

Intervention Type: Other

Intervention Name: Virtual Collaborative Care Clinic

Description: The vCCC will operate under a collaborative care agreement with the Primary Care Physicians as an extension (and not a replacement) of their care. Trained clinical pharmacists will monitor blood pressure and prescribe and adjust medications under the license of, and in communication with, the patient's Primary Care Physician. As part of the Primary Care Physician's team and per Primary Care Physician's directions, the pharmacists may coordinate blood pressure management with other clinicians such as cardiologists or nephrologists co-managing patients blood pressure.

Arm Group Label: Virtual Collaborative Care Clinic

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

Gender: All

Minimum Age: 65 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jeffrey Burns, MD Principal Investigator University of Kansas Medical Center
Location
Facility: University of Kansas Medical Center
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Kansas Medical Center

Investigator Full Name: Jeff Burns, MD

Investigator Title: Co-Director Alzheimer's Disease Center

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Virtual Collaborative Care Clinic

Type: Experimental

Description: The Virtual Collaborative Care Clinic arm participants use a home blood pressure monitor and routine blood pressure measurements will be uploaded to a dashboard monitored by clinical pharmacists. Blood pressure will be managed aggressively by the clinical pharmacists in coordination with Primary Care Physicians.

Label: Control Intervention

Type: No Intervention

Description: The control intervention will consist of providing the participant with educational material and a home blood pressure monitor. The patients in the control group will not have support from Virtual Collaborative Care Clinic pharmacists. Routine blood pressure measures using their device will not be collected via the dashboard and will not be available for pharmacist review. Participants will continue to see their physicians for their usual care for blood pressure management.

Acronym vCCC
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov