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Patient Navigator Intervention for Diabetic Retinopathy (SEEN)

Primary Purpose

Diabetic Retinopathy, Diabetic Blindness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, diabetic blindness, patient navigator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

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

Outcomes

Primary Outcome Measures

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
Number of participants who completed a follow-up eye exam 12+ months after baseline eye exam
The number of participants who completed a follow-up eye exam 12+ months after baseline eye exam will be determined using the electronic health record

Secondary Outcome Measures

Full Information

First Posted
December 22, 2021
Last Updated
September 25, 2023
Sponsor
Yale University
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT05188703
Brief Title
Patient Navigator Intervention for Diabetic Retinopathy
Acronym
SEEN
Official Title
Undiagnosed Diabetic Retinopathy: Using Participatory Science to Design an Intervention for Patients at High-Risk for Blindness
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
January 14, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Diabetic Blindness
Keywords
diabetic retinopathy, diabetic blindness, patient navigator

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm study. All participants will receive the intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Intervention consists of standard of care eye exam and enrollment in a patient navigation program.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention Description
Participants will be assigned to a patient navigator and will have quarterly appointments. Patient navigators will assist with access and coordination of medical care.
Primary Outcome Measure Information:
Title
Number of participant who had baseline eye exam
Description
The number of participants who had their baseline eye exam will be determined using the electronic health record
Time Frame
18 months
Title
Number of participants who completed a follow-up eye exam 12+ months after baseline eye exam
Description
The number of participants who completed a follow-up eye exam 12+ months after baseline eye exam will be determined using the electronic health record
Time Frame
up to 18 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Nwanyanwu, MD, MHS
Phone
203-785-2020
Email
k.nwanyanwu@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Nwanyanwu, MD, MHS
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Assanah, MD
Phone
203-361-4659
Email
brittany.assanah@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to make IPD available to other researchers.
Citations:
PubMed Identifier
34426057
Citation
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.
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Patient Navigator Intervention for Diabetic Retinopathy

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