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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 below

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I am 18 years old or older.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6+2 (8) months post-discharge for reporting.

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 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: 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

0 / 2Eligibility criteria met