Patient Navigation for Diabetic Retinopathy

(SEEN Trial)

Overseen By Kristen Nwanyanwu, MD, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Recent eye exam, Low retinopathy risk, others

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

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a program to help people with diabetes who are at high risk of going blind. The program will guide these patients to ensure they get the necessary eye exams. The goal is to improve screening rates and prevent blindness, especially in minority and low-income communities.

Research Team

Kristen Nwanyanwu, MD, MHS

Principal Investigator

Yale University

Eligibility Criteria

This trial is for English-speaking adults over 18 with diabetes, who haven't had an eye exam in the past year and are at high risk for diabetic retinopathy according to a risk calculator. They must have their diabetes diagnosis recorded in YNHHS EPIC.

Inclusion Criteria

I have been diagnosed with diabetes, and it is recorded in the YNHHS EPIC system.

No documented eye examination within 1 year of study enrollment

You have a high chance of developing eye problems related to diabetes according to a risk calculator.

Exclusion Criteria

Your diabetes diagnosis is not in the EPIC medical records.

Documented eye exam in the past year

I am not at high risk for vision problems due to diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a standard of care eye exam and are enrolled in a patient navigation program

18 months

Follow-up

Participants are monitored for completion of follow-up eye exams 12+ months after baseline

up to 18 months

Treatment Details

Interventions

• Patient Navigation

Trial Overview The study is testing a patient navigator program designed to help people with diabetes avoid blindness from diabetic retinopathy. It's a pilot study to see if this approach is practical and well-received before moving on to a larger clinical trial.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

Intervention consists of standard of care eye exam and enrollment in a patient navigation program.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+