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Clinical Trials/NCT04585880
NCT04585880
Completed
Not Applicable

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

University of Kansas Medical Center1 site in 1 country33 target enrollmentOctober 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Kansas Medical Center
Enrollment
33
Locations
1
Primary Endpoint
Feasibility of system wide adoptability as assessed by survey responses
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2020
End Date
July 2, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeff Burns, MD

Co-Director Alzheimer's Disease Center

University of Kansas Medical Center

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

Outcomes

Primary Outcomes

Feasibility of system wide adoptability as assessed by survey responses

Time Frame: 3 Months Post Baseline

Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.

Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion

Time Frame: Through study completion, an average of 9 months

Members of the Physician Advisory Board will be asked for feedback on system wide adoptability during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.

Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews

Time Frame: Up to 2 months Post Baseline

Virtual Collaborative Care Clinic Pharmacists will be asked for feedback on feasibility of system wide adoption. We will conduct one-time semi-structured qualitative interviews with the Virtual Collaborative Care Clinic pharmacists. The Virtual Collaborative Care Clinic pharmacist will be interviewed to assess implementation factors including the auto-referral process and open-ended questions on the process and suggestions for improvement.

Replicability to other health systems as assessed by survey responses

Time Frame: 3 Months Post Baseline

Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.

Replicability to other health systems as assessed by Physician Advisory Board meetings discussion

Time Frame: Through study completion, an average of 9 months

Members of the Physician Advisory Board will be asked for feedback on replicability to other health systems during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.

Replicability to other health systems as assessed by vCCC Pharmacist Interviews

Time Frame: Up to 2 months Post Baseline

vCCC Pharmacists will be asked for feedback on replicability to other health systems. We will conduct one-time semi-structured qualitative interviews including open-ended questions.

Study Sites (1)

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