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Remote Monitoring and Telehealth for High Blood Pressure (vCCC 2 Trial)

N/A
Recruiting
Led By Jeffrey Burns, MD, MS
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hearing to complete study procedures
Adequate hearing to complete study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

vCCC 2 Trial Summary

This trial is designed to test a hypertension program that uses a virtual clinic, home monitoring, and telehealth to lower blood pressure.

Who is the study for?
This trial is for people aged 65 and older with high blood pressure who can hear well, speak English, use a smartphone or similar device, and have Medicare. They must not be in hospice care, on dialysis for kidney failure, receiving chemotherapy or other trials' interventions, diagnosed with dementia or any severe illness that could interfere with the study.Check my eligibility
What is being tested?
The trial tests a virtual hypertension management program combining home blood pressure monitoring and telehealth to lower blood pressure. Participants are randomly assigned to either receive this new virtual Collaborative Care Clinic (vCCC) approach or continue their usual care.See study design
What are the potential side effects?
Since the intervention involves remote monitoring and virtual consultations rather than medication changes or invasive procedures, side effects may include discomfort from frequent BP measurements or potential stress related to technology use.

vCCC 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can hear well enough to follow study instructions.
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I can hear well enough to follow study instructions.
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I have high blood pressure with a reading over 140 or had a reading over 160.
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I can sign the consent form myself.
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I am 65 years old or older.

vCCC 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Systolic Blood Pressure (SBP) Control At 24 Months
Secondary outcome measures
Atherosclerotic Cardiovascular Disease Risk (ASCVD)
Cognitive Measures
Health Care Resource Utilization: Charges Per Patient
+13 more

vCCC 2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Collaborative Care ClinicExperimental Treatment1 Intervention
Participants will partake in the virtual collaborative care clinic
Group II: Usual Care with EducationActive Control1 Intervention
The participant will be provided with educational material and a home BP monitor. Control participants will continue to see their physicians for their usual care for BP management (their BP data will not be reviewed by pharmacists and the patients will not have support from vCCC pharmacists)

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaOTHER
360 Previous Clinical Trials
626,964 Total Patients Enrolled
University of UtahOTHER
1,092 Previous Clinical Trials
1,731,592 Total Patients Enrolled
University of Kansas Medical CenterLead Sponsor
459 Previous Clinical Trials
168,104 Total Patients Enrolled

Media Library

Virtual Collaborative Care Clinic Clinical Trial Eligibility Overview. Trial Name: NCT05138601 — N/A
High Blood Pressure Research Study Groups: Usual Care with Education, Virtual Collaborative Care Clinic
High Blood Pressure Clinical Trial 2023: Virtual Collaborative Care Clinic Highlights & Side Effects. Trial Name: NCT05138601 — N/A
Virtual Collaborative Care Clinic 2023 Treatment Timeline for Medical Study. Trial Name: NCT05138601 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the magnitude of participants involved in this research?

"Affirmative. Clinicaltrials.gov declares that this medical experiment is still recruiting participants, having originally been posted on 16th November 2021 and most recently updated 15th August 2022. The research requires 1000 individuals from a single site to partake in the trial."

Answered by AI

Does this research endeavor have any open spots for participants?

"Affirmative. As per the information on clinicaltrials.gov, this medical investigation is actively enrolling participants. The trial was posted on November 16th 2021 and has since been updated multiple times, most recently being on August 15th 2022. This study requires 1000 individuals from a single site to participate in order for it to move forward."

Answered by AI

Who else is applying?

What site did they apply to?
University of Kansas Health System
What portion of applicants met pre-screening criteria?
Met criteria
~462 spots leftby Mar 2026