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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04585880
Acronym
vCCC
Enrollment
33
Registered
2020-10-14
Start date
2020-10-20
Completion date
2021-07-02
Last updated
2021-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Hypertension

Keywords

Hypertension, Cognitive Decline, Mild Cognitive Decline, Memory Loss, Memory Disorders, Memory Impairment, Blood Pressure, Blood Pressure, High

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.

Interventions

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Kansas Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of system wide adoptability as assessed by survey responsesBaselinePrimary 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 discussionThrough study completion, an average of 9 monthsMembers 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 InterviewsUp to 2 months Post BaselineVirtual 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 responsesBaselinePrimary 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 discussionThrough study completion, an average of 9 monthsMembers 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 InterviewsUp to 2 months Post BaselinevCCC 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026