N/A
N=33
Patient Navigator Intervention for Diabetic Retinopathy
Diabetic Retinopathy · Diabetic Blindness
Bottom Line
View on ClinicalTrials.gov: NCT05188703 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participant Who Had Baseline Eye Exam — 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Navigation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant Who Had Baseline Eye Exam |
33 | — |
| PRIMARY Percentage of Participants Who Completed a Follow-up Eye Exam 12-18 Months After Baseline Eye Exam |
71 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05188703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.