Patient Education for Cardiovascular Health

Recruiting at 1 trial location

Overseen By Etta Pisano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American College of Radiology

Disqualifiers: Cad, Prior heart surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

800 Participants Needed

Trial Summary

What is the purpose of this trial?

This multicenter clustered randomized prospective study will be managed by the American College of Radiology Center for Research and Innovation (ACR CRI). The research team aims to test the efficacy of a patient-centered educational intervention based on coronary artery calcification (CAC) information in cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.

Eligibility Criteria

This trial is for current or former smokers aged 50-80 who've had a low-dose CT scan for lung cancer screening within the last month. Participants should have smoked more than 20 pack-years. Those with known coronary artery disease, past heart surgeries, language barriers, or without stable contact information cannot join.

Inclusion Criteria

I am between 50 and 80 years old.

I am currently smoking or quit smoking within the last 15 years.

I had a low-dose CT scan for lung cancer within the last 30 days.

Exclusion Criteria

I have a history of heart disease or have had heart surgery.

Patients unable to understand the informed consent process

Patients without a contact phone number or permanent address to receive the study intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline Assessment

Participants complete a baseline questionnaire on demographics, cardiovascular health, and lifestyle habits

1-2 weeks

1 visit (virtual)

Intervention

Participants in the intervention group receive an educational letter based on coronary calcium score

8 weeks

1 visit (virtual or mail)

Follow-up

Participants complete a follow-up questionnaire to assess changes in lifestyle and cardiovascular health

6 months

1 visit (virtual or mail)

Treatment Details

Interventions

• Educational Letter Post CT Examination

Trial Overview The study evaluates if an educational letter about heart health sent after a CT scan can help people understand and manage their risk of heart disease better. It's conducted by ACR CRI across multiple centers and randomly assigns patients to receive this intervention.

Participant Groups

Group I: Letter Recipients with Coronary Calcium Score/Educational Materials Experimental Treatment 1 Intervention

Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination.

Group II: Non-Letter Recipients (Control) Active Control 1 Intervention

Patients in the control group will not receive any letter in the mail with their coronary calcium score and educational materials.

Who Is Running the Clinical Trial?

American College of Radiology

Lead Sponsor

Trials

24

Recruited

8,055,000+