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OpenTrials
Completed

NCT Number: NCT04585880

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Collaborative Care Clinic

Other

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 outcomes

  1. Feasibility of system wide adoptability as assessed by survey responses

    Time frame: 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.

  2. 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.

  3. 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.

  4. 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.

  5. Replicability to other health systems as assessed by survey responses

    Time frame: 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: vCCC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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