Patient Navigator Intervention for Diabetic Retinopathy

NCT05188703 | Completed Results

• 2 other identifiers: 20000317311K23EY030530-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Retinopathy; Diabetic Blindness

Keywords

diabetic retinopathy; diabetic blindness; patient navigator

Outcome Measures

Primary Outcomes (2)

• Number of Participant Who Had Baseline Eye Exam

  The number of participants who had their baseline eye exam will be determined using the electronic health record

  baseline

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

  Percentage of participants who completed a follow-up eye exam 12-18 months after baseline eye exam will be determined using the electronic health record

  up to 18 month

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Behavioral: Patient Navigation

Interventions

Patient Navigation BEHAVIORAL

Participants will be assigned to a patient navigator and will have quarterly appointments. Patient navigators will assist with access and coordination of medical care.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Documented eye exam in the past year
• Not high risk for diabetic retinopathy
• Diabetes diagnosis not recorded in EPIC

Sponsors & Collaborators

• National Eye Institute (NEI): collaborator
• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Nwanyanwu KMJH, Nunez-Smith M, Gardner TW, Desai MM. Awareness of Diabetic Retinopathy: Insight From the National Health and Nutrition Examination Survey. Am J Prev Med. 2021 Dec;61(6):900-909. doi: 10.1016/j.amepre.2021.05.018. Epub 2021 Aug 21.

  PMID: 34426057 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Alvaro Granados
• Organization: Research Associate

alvaro.granados@yale.edu

203-785-2020

Study Officials

• Kristen Nwanyanwu, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm study. All participants will receive the intervention.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 12, 2022
• Study Start: July 25, 2022
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)