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Pharmacist-Led Cardiovascular Risk Service for Reducing Heart Disease Risk (CVRSLive Trial)
N/A
Waitlist Available
Led By Korey Kennelty, PharmD
Research Sponsored by Korey Kennelty
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently has one of the following diseases: Diabetes with HA1c 9.0% or greater and/or Hypertension (uncomplicated) with systolic blood pressure 150 mm Hg or greater
Be older than 18 years old
Must not have
Inability to give consent
Diagnosis of dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months following the start of recruitment
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how effective a remote, pharmacist-led cardiovascular risk service is in 12 hospitals with diverse patients.
Who is the study for?
This trial is for English or Spanish speakers who have visited the clinic in the past year and are currently managing diabetes with an HA1c of 9.0%+ or high blood pressure with a systolic reading of 150 mm Hg+. It's not open to those unable to consent, living in nursing homes, without a phone, diagnosed with short-term cancer prognosis, pregnant women, dementia patients, or planning to leave the clinic soon.
What is being tested?
The study is testing a remote cardiovascular risk service led by pharmacists across diverse hospitals. The aim is to see how well this service can be implemented in different settings and its effectiveness for patients with high blood pressure and diabetes.
What are the potential side effects?
Since this intervention involves a non-medical service focusing on cardiovascular risk management rather than medication or procedures, traditional side effects are not applicable. However, there may be indirect effects related to changes in health management.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have diabetes with an HA1c of 9.0% or higher, or I have hypertension with a systolic blood pressure of 150 mm Hg or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand and give consent for treatment.
Select...
I have been diagnosed with dementia.
Select...
I live in a nursing home.
Select...
My doctor expects I have less than 2 years to live due to my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months following the start of recruitment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months following the start of recruitment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effect of physician/pharmacist collaboration on implementation fidelity
Factors influencing intervention implementation fidelity
Secondary study objectives
Adherence to guidelines for primary and secondary prevention of cardiovascular disease
Development of payment contracts
Reach and adoption of intervention
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
Group I: CVRS Early InterventionExperimental Treatment1 Intervention
Patients participating in intervention offices will receive the pharmacist-led CVRS intervention for 12 months.
Group II: CVRS Delayed InterventionExperimental Treatment1 Intervention
Patients participating in control site offices will not have any contact with the CVRS pharmacist for the first 12 months of their participation in the study. They will receive the study intervention during months 13-24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CVRS Intervention
2015
N/A
~410
Find a Location
Who is running the clinical trial?
Korey KenneltyLead Sponsor
3 Previous Clinical Trials
724 Total Patients Enrolled
Korey Kennelty, PharmDPrincipal InvestigatorUniversity of Iowa