Patient Navigation for Diabetic Retinopathy

(SEEN Trial)

Overseen By Kristen Nwanyanwu, MD, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Recent eye exam, Low retinopathy risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to assist people with diabetes who are at high risk of vision loss. The goal is to determine if a patient navigator—someone who guides and supports patients through their healthcare journey—is helpful and practical. Participants will receive a standard eye exam and join the patient navigation program. The trial seeks English-speaking individuals with diabetes who haven't had an eye exam in the past year and are at high risk for diabetic retinopathy, an eye disease related to diabetes. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions and potentially enhance personal care experiences.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on assessing a patient navigator intervention rather than medication changes.

What prior data suggests that this patient navigation intervention is safe?

Research has shown that patient navigation, which guides individuals through the healthcare system, is generally well-received. Studies have found that it can help manage blood sugar levels and improve understanding of diabetes care. Reports of major negative effects from these programs are absent, suggesting that patient navigation is safe and beneficial for people with diabetes, particularly those at high risk for diabetic retinopathy, an eye condition that can lead to blindness. These programs primarily focus on improving access to care and supporting patients, rather than introducing new medications or procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the patient navigation program for diabetic retinopathy because it offers a personalized approach to managing the condition. Unlike standard treatments that primarily focus on medical interventions like laser therapy or injections, this program emphasizes guiding patients through the healthcare system. By ensuring they attend eye exams and follow up on care, the program aims to improve outcomes through better patient engagement and adherence. This innovative approach could lead to more effective management of diabetic retinopathy by addressing the gaps in patient support and access to essential eye care.

What evidence suggests that patient navigation is effective for diabetic retinopathy?

Research has shown that patient navigation can improve health outcomes for people with diabetes. One study found that participants in a patient navigation program managed their blood sugar levels more effectively, took better care of themselves, and gained more knowledge about diabetes. In this trial, participants in the intervention arm will receive standard eye exams and enroll in a patient navigation program. This approach might help prevent diabetic eye disease by encouraging regular eye check-ups and better diabetes management. By improving access to care and support, patient navigation may lower the risk of blindness from diabetes. These findings offer hope for those at high risk of diabetic eye problems. ^{1 2 4 5 6}

Who Is on the Research Team?

Kristen Nwanyanwu, MD, MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with diabetes, and it is recorded in the YNHHS EPIC system.

No documented eye examination within 1 year of study enrollment

You have a high chance of developing eye problems related to diabetes according to a risk calculator.

Exclusion Criteria

Your diabetes diagnosis is not in the EPIC medical records.

Documented eye exam in the past year

I am not at high risk for vision problems due to diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a standard of care eye exam and are enrolled in a patient navigation program

18 months

Follow-up

Participants are monitored for completion of follow-up eye exams 12+ months after baseline

up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05188703

Patient Navigator Intervention for Diabetic Retinopathy 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10433589/

The impact of patient navigation on glycemic control ... Our results showed improvement in glycemic control, adherence to self-care, and knowledge of diabetes in the study participants. In addition, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9200294/

Associations between healthcare utilization and access ... This study assesses whether social determinants were associated with an increased risk of developing proliferative diabetic retinopathy or related ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840380

Diabetic Retinopathy Screening Among Federally Qualified ... This trial protocol describes a multicomponent randomized clinical trial that integrated an artificial intelligence (AI)–powered diabetic ...

5. researchgate.net researchgate.net/publication/321196823_Patient_navigation_to_improve_diabetes_outpatient_care_at_a_safety-net_hospital_A_retrospective_cohort_study

(PDF) Patient navigation to improve diabetes outpatient ... The objective of this study was to evaluate the effect of a patient navigation program on medical and administrative outcomes among patients ...

6. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2791060

Care Coordinations' Effect on Screening for Diabetic ... - IOVS Conclusions : Care coordination and patient navigation may address social determinants of health and the population that is at high risk of diabetic retinopathy ...