CompletedNot Applicable

Patient Navigator Intervention for Diabetic Retinopathy

United States35 participantsStarted 2022-07-25

Plain-language summary

This is a pilot study of a patient navigator intervention for people living with diabetes and at high risk of diabetic blindness. The investigators are assessing the feasibility and acceptability of the intervention in preparation for a clinical trial.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 and over * Diagnosis of diabetes and record of diagnosis in YNHHS EPIC * English-speaking * No documented eye examination within 1 year of study enrollment * High risk for diabetic retinopathy based on risk calculator evaluation Exclusion Criteria: * Documented eye exam in the past year * Not high risk for diabetic retinopathy * Diabetes diagnosis not recorded in EPIC

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participant Who Had Baseline Eye Exam

Timeframe: baseline

Percentage of Participants Who Completed a Follow-up Eye Exam 12-18 Months After Baseline Eye Exam

Timeframe: up to 18 month

Trial details

NCT IDNCT05188703

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-19

Results submitted2025-09-16

View on ClinicalTrials.gov More Diabetic Retinopathy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.