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Education and Support for Cardiovascular Disease (T2T Trial)
N/A
Recruiting
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years old
Admitted with Type 1 NSTEMI or STEMI, and/or percutaneous coronary revascularization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6+2 (8) months post-discharge
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine if educating doctors and providing follow-up support to patients who have had a heart event can help prevent future heart problems. The study will look at whether educating doctors increases the frequency of
Who is the study for?
This trial is for adults over 18 who've been hospitalized with a heart event like NSTEMI or STEMI, or have had coronary revascularization. They must be managed by a doctor within the health system post-discharge and have LDL cholesterol levels of ≥70 mg/dL during admission.
What is being tested?
The study tests if educating doctors and assigning a 'care champion' to call patients after hospital discharge can improve cholesterol management in heart event patients. It measures how many reach their cholesterol goals with versus without this intervention.
What are the potential side effects?
Since the intervention involves education and phone calls rather than medication, there are no direct medical side effects. However, participants may experience stress or anxiety from discussing their health condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I was admitted for a heart attack or had a procedure to open my heart's arteries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6+2 (8) months post-discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6+2 (8) months post-discharge
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Within-patient change in LDL-C (low-density lipoprotein cholesterol) from baseline (during admission) to last LDL-C level checked within 6+2 (8) months post-discharge
Secondary study objectives
Number of participants with LDL-C (low-density lipoprotein cholesterol) elevated on initial re-check (post-discharge) who get LLT uptitrated (initiated and/or increased dose) within 4 weeks of LDL-C test
Number of participants with a change in LLT (lipid-lowering therapy) within 6 months post-discharge
Time to LDL-C (low-density lipoprotein cholesterol) control
Other study objectives
Adaptations made to algorithm at each site
Clinician satisfaction assessed by a scale that is still to be determined.
Number of calls to each patient
+11 moreAwards & 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: Care Champion InterventionExperimental Treatment1 Intervention
The participants randomized to the intervention arm will have a care champion help to navigate their inpatient-to-outpatient transition and lipid care. They will be introduced to the intervention before discharge by the CRC who has enrolled them. This will include a virtual introduction to the care champion, delivery of contact information, and expectations around communication from the care champion in the coming months. It will also include clear education around the patient's LDL-C goals, lipid management plan, plans for re-testing, and outpatient follow-up.
Group II: Standard of CareActive Control1 Intervention
Standard of Care
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,462 Previous Clinical Trials
2,968,520 Total Patients Enrolled
AmgenIndustry Sponsor
1,457 Previous Clinical Trials
1,400,256 Total Patients Enrolled