← Back to Search

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

N/A

Waitlist Available

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

Able to give their own signed consent

Must not have

End stage kidney disease on dialysis

Currently receiving chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can hear well enough to follow study instructions.

Select...

I can sign the consent form myself.

Select...

I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am on dialysis for end-stage kidney disease.

Select...

I am currently undergoing chemotherapy.

Select...

I am currently receiving hospice care.

Select...

I cannot have my blood pressure accurately measured due to certain medical conditions or inability to follow the protocol.

Select...

I have been diagnosed with a form of dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Systolic Blood Pressure (SBP) Control At 24 Months

Secondary study objectives

Atherosclerotic Cardiovascular Disease Risk (ASCVD)

Cognitive Measures

Health Care Resource Utilization: Charges Per Patient

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 8Eligibility criteria met