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Patient Navigator Intervention for Diabetic Retinopathy

Undiagnosed Diabetic Retinopathy: Using Participatory Science to Design an Intervention for Patients at High-Risk for Blindness

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05188703
Acronym
SEEN
Enrollment
35
Registered
2022-01-12
Start date
2022-07-25
Completion date
2024-09-19
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Blindness, Diabetic Retinopathy

Keywords

diabetic retinopathy, diabetic blindness, patient navigator

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.

Detailed description

Evidence-based treatment for Diabetic retinopathy (DR) established 30 years ago decreases the likelihood of blindness by 50%. Outcomes are even better now with emerging therapies and technology. Diabetes remains the leading cause of new cases of legal blindness. This study is significant because it investigates the gap between published guidelines and the population that continues to go blind despite well-established recommendations for screening. Our current model of screening for DR screens much of the population appropriately. There is an opportunity to improve DR screening by timely identification of persons at risk for preventable blindness. DR disproportionately impacts Non-Hispanic Blacks, Latinos, Native Americans, and lower socioeconomic communities. Racial and ethnic minorities are less likely to be screened for DR, have a higher prevalence of disease, and more severe disease. There is not a clear path toward decreasing these disparities beyond these data. This study addresses barriers to the implementation of evidenced-based treatment protocols by identifying modifiable patient and population-level challenges and building an intervention informed by community members and national data. It is a direct response to the "population health imperative" described by the National Academies of Science, Engineering, and Medicine. Our study answers the National Eye Institute's Strategic Plan request to evaluate disparities by identifying barriers that prevent optimal treatment. It is aligned with the NEI's mission to support research and training with respect to the preservation of sight. The National Institute on Minority Health and Health Disparities Research Framework provides the conceptual foundation for our work. Our proposal identifies facets of the biologic, built, and sociocultural environments of the national population with undiagnosed DR. The national analysis informs a local individual-level intervention that addresses determinants associated with DR screening. The scientific premise of this study is the forty percent of persons with diabetes not screened despite established sight-saving treatment, the known disparities in screening for DR, and the increased prevalence of sight-threatening DR in Black, Latino, Native, and lower income Americans. Primary Objective The primary objective of this study is to design and pilot a patient navigator program to increase screening for DR in a high-risk population. Secondary Objective To determine the feasibility and accessibility of a patient navigation program for persons at high-risk for DR.

Interventions

BEHAVIORALPatient Navigation

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

Sponsors

Yale University
Lead SponsorOTHER
National Eye Institute (NEI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participant Who Had Baseline Eye ExambaselineThe number of participants who had their baseline eye exam will be determined using the electronic health record
Percentage of Participants Who Completed a Follow-up Eye Exam 12-18 Months After Baseline Eye Examup to 18 monthPercentage of participants who completed a follow-up eye exam 12-18 months after baseline eye exam will be determined using the electronic health record

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKristen Nwanyanwu, MD, MHS

Yale University

Participant flow

Pre-assignment details

35 participants signed consent, 2 lost to follow up prior to starting intervention, 33 participants started the intervention.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
6 Participants
Age, Categorical
Between 18 and 65 years
29 Participants
Age, Continuous52.26 years
STANDARD_DEVIATION 13.65
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
15 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
13 Participants
Region of Enrollment
United States
35 participants
Sex: Female, Male
Female
18 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 35
other
Total, other adverse events
0 / 35
serious
Total, serious adverse events
0 / 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026