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Patient Navigation for Diabetic Retinopathy (SEEN Trial)

N/A
Recruiting
Led By Kristen Nwanyanwu, MD, MHS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of diabetes and record of diagnosis in YNHHS EPIC
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

SEEN Trial Summary

This trial is testing a patient navigator intervention to help people with diabetes who are at high risk of diabetic blindness. They want to see if it's feasible and acceptable before doing a bigger clinical trial.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves guidance rather than medication, there aren't typical drug side effects. However, participants may experience stress or anxiety related to managing their condition more closely.

SEEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with diabetes, and it is recorded in the YNHHS EPIC system.

SEEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participant who had baseline eye exam
Number of participants who completed a follow-up eye exam 12+ months after baseline eye exam

SEEN Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
Intervention consists of standard of care eye exam and enrollment in a patient navigation program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation
2017
Completed Phase 2
~38910

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,406 Total Patients Enrolled
National Eye Institute (NEI)NIH
547 Previous Clinical Trials
1,402,122 Total Patients Enrolled
50 Trials studying Diabetic Retinopathy
42,910 Patients Enrolled for Diabetic Retinopathy
Kristen Nwanyanwu, MD, MHSPrincipal InvestigatorYale School of Medicine

Media Library

Patient Navigation Clinical Trial Eligibility Overview. Trial Name: NCT05188703 — N/A
Diabetic Retinopathy Research Study Groups: Intervention arm
Diabetic Retinopathy Clinical Trial 2023: Patient Navigation Highlights & Side Effects. Trial Name: NCT05188703 — N/A
Patient Navigation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05188703 — N/A
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05188703 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enrolled in the clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov attests that this medical experiment, initially published on July 25th 2022 is recruiting participants as of now. Approximately 60 individuals are set to be enrolled in the trial at its lone site."

Answered by AI

Has this research been opened up to new participants yet?

"That is correct. According to the information readily available on clinicaltrials.gov, this research project posted in late July 2022 and was recently updated at the beginning of September 2022 seeks 60 participants from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
New York
Louisiana
What site did they apply to?
Yale School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I want to cure or slow my retinopathy. I have tried many drug that have NOT worked and slowly loosing vision in my good eye. Please help!!
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Yale School of Medicine: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
American Journal of Preventive MedicineJournal
Awareness of Diabetic Retinopathy: Insight from the National Health and Nutrition Examination Survey
Nwanyanwu, Kristen M.J.H., Marcella Nunez-Smith, Thomas W. Gardner, and Mayur M. Desai. 2021. “Awareness of Diabetic Retinopathy: Insight from the National Health and Nutrition Examination Survey”. American Journal of Preventive Medicine. Elsevier BV. doi:10.1016/j.amepre.2021.05.018.
clinicaltrials.govStudy
Patient Navigator Intervention for Diabetic Retinopathy
2022. "Patient Navigator Intervention for Diabetic Retinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05188703.
All > Diabetic Retinopathy
~10 spots leftby Jan 2025
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