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

Hypertension Clinical Trial

— vCCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585880
• Other study ID #: STUDY146086
• Secondary ID: 1R61AG068483-01
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: July 2, 2021

Study information

• Verified date: July 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Hypertension

Intervention

Other:
• Virtual Collaborative Care Clinic
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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of system wide adoptability as assessed by survey responses	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.	Baseline
Primary	Feasibility of system wide adoptability as assessed by survey responses	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.	3 Months Post Baseline
Primary	Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion	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.	Through study completion, an average of 9 months
Primary	Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews	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.	Up to 2 months Post Baseline
Primary	Replicability to other health systems as assessed by survey responses	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.	Baseline
Primary	Replicability to other health systems as assessed by survey responses	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.	3 Months Post Baseline
Primary	Replicability to other health systems as assessed by Physician Advisory Board meetings discussion	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.	Through study completion, an average of 9 months
Primary	Replicability to other health systems as assessed by vCCC Pharmacist Interviews	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.	Up to 2 months Post Baseline