Back to resultsRemote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline (vCCC)
Primary Purpose
Hypertension, Cognitive Decline
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Collaborative Care Clinic
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Cognitive Decline, Mild Cognitive Decline, Memory Loss, Memory Disorders, Memory Impairment, Blood Pressure, Blood Pressure, High
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Collaborative Care Clinic
Control Intervention
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04585880
First Posted
September 30, 2020
Last Updated
July 7, 2021
Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04585880
Brief Title
Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline
Acronym
vCCC
Official Title
Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cognitive Decline
Keywords
Hypertension, Cognitive Decline, Mild Cognitive Decline, Memory Loss, Memory Disorders, Memory Impairment, Blood Pressure, Blood Pressure, High
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Collaborative Care Clinic
Arm Type
Experimental
Arm 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.
Arm Title
Control Intervention
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Virtual Collaborative Care Clinic
Intervention 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.
Primary Outcome Measure Information:
Title
Feasibility of system wide adoptability as assessed by survey responses
Description
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.
Time Frame
Baseline
Title
Feasibility of system wide adoptability as assessed by survey responses
Description
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.
Time Frame
3 Months Post Baseline
Title
Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews
Description
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.
Time Frame
Up to 2 months Post Baseline
Title
Replicability to other health systems as assessed by survey responses
Description
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.
Time Frame
Baseline
Title
Replicability to other health systems as assessed by survey responses
Description
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.
Time Frame
3 Months Post Baseline
Title
Replicability to other health systems as assessed by Physician Advisory Board meetings discussion
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Replicability to other health systems as assessed by vCCC Pharmacist Interviews
Description
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.
Time Frame
Up to 2 months Post Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Burns, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline
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