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Team-Delivered Intervention for Cardiovascular Disease (CARE Trial)
N/A
Waitlist Available
Led By Julie Christina Gass, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A diagnosis of cardiac disease, including coronary artery disease, hypertension, hyperlipidemia, OR ischemia
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post intervention
Awards & highlights
CARE Trial Summary
This trial is testing a new approach to talking to patients about heart disease and health behaviors in order to see if it impacts how patients feel and behave.
Who is the study for?
This trial is for Veterans with heart disease who smoke or drink hazardously. They must be attending a primary care appointment soon, have moderate intentions to change their behavior, and consistently report smoking or hazardous drinking. Those with severe mental impairment, non-English speakers, or non-Veterans are excluded.Check my eligibility
What is being tested?
The study tests a new approach where a Health Educator extends the patient's primary care visit by about 5 minutes to discuss heart health and behaviors versus just the standard care. Participants will also have follow-up calls and access to an optional health-tracking app.See study design
What are the potential side effects?
Since this intervention involves counseling rather than medication, typical medical side effects aren't expected. However, participants may experience emotional discomfort discussing personal habits like smoking and drinking.
CARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a heart condition.
CARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Readiness to Change drinking OR smoking
Readiness to change drinking OR smoking
Secondary outcome measures
Alcohol Use Disorders Identification Test (AUDIT)
Cigarettes per day
Nicotine dependence
+1 moreCARE Trial Design
2Treatment groups
Experimental Treatment
Group I: CARE-PCMHIExperimental Treatment1 Intervention
30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator
Group II: CARE-PACTExperimental Treatment1 Intervention
Brief (5 minute) meeting between the PACT medical provider and a behavioral health educator (in person or virtual using VA's VVC system) -followed by- 30 minute meeting alone with behavioral health educator (in person or virtual using VA's VVC system) 4 weeks of optional self monitoring using an app 2 optional 15-minute phone calls with behavioral health educator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CARE
2019
N/A
~200
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,563 Total Patients Enrolled
Julie Christina Gass, PhDPrincipal InvestigatorVA Western New York Healthcare System, Buffalo, NY
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a scheduled PACT appointment.I am somewhat motivated (up to a 7 out of 10) to change my drinking or smoking habits.I am over 18 and a veteran patient at the Buffalo VAMC.You currently smoke at least one cigarette per day or have a drinking problem based on a test.I have been diagnosed with a heart condition.You have been consistently using alcohol or tobacco for at least two years, including recently.
Research Study Groups:
This trial has the following groups:- Group 1: CARE-PCMHI
- Group 2: CARE-PACT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled positions in this clinical exploration?
"Clinicialtrials.gov suggests that this medical trial is not seeking participants at present, having last been updated on May 16th 2022 and initially posted on the 13th of same month. Fortunately, 418 other studies are actively recruiting patients as we speak."
Answered by AI
What results is the team striving to achieve through this clinical experiment?
"The primary purpose of this clinical trial, to be assessed over a 6 week period post-intervention, is the determination of participants' readiness to stop consuming alcohol or smoking. Secondary objectives include measurement of severity in terms of Alcohol Use Disorders Identification Test (AUDIT), Nicotine Dependence Symptom Severity scales and Cigarette per Day count for smokers respectively."
Answered by AI
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