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Compensation: Varies

Number of Visits: Unknown

749 Participants Needed

Vision Screening + Patient Navigation for Eye Diseases

Overseen ByJames Auran, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Terminal illness, Dementia, others

Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Enhanced Intervention Using Patient Navigators for eye diseases?

The research on diabetic retinopathy screening shows that involving key stakeholders like patients and providers, and reinforcing patient education, can improve screening rates. This suggests that using patient navigators, who help guide patients through the healthcare system, might also enhance follow-up care and treatment adherence for eye diseases.¹ ² ³ ⁴ ⁵

Is the Vision Screening + Patient Navigation for Eye Diseases treatment safe for humans?

The research articles reviewed do not provide specific safety data for the Vision Screening + Patient Navigation treatment, but they do discuss interventions like patient navigators, which are generally considered safe as they focus on improving follow-up care and patient education.¹ ² ³ ⁶ ⁷

How does the Usual Care treatment for eye diseases differ from other treatments?

Usual Care for eye diseases typically involves standard practices like regular eye exams and follow-up care, but it may not address barriers to accessing care, such as socioeconomic factors or lack of awareness. The Vision Screening + Patient Navigation approach aims to improve access and adherence by guiding patients through the healthcare system, which is particularly beneficial for those in disadvantaged communities.¹ ⁴ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

The investigators are conducting a 5-year prospective, 2:1 cluster-randomized controlled trial, funded by the Centers for Disease Control (CDC), which provides vision screenings to underserved New York City residents living in affordable housing buildings in Harlem and Washington Heights.

Research Team

Lisa A. Hark, PhD, RD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for people over 40 living independently in NYCHA housing or attending DFTA Senior Centers in Harlem and Washington Heights, willing to undergo two vision screenings. Those with terminal illness or unable to consent due to dementia cannot participate.

Inclusion Criteria

I am over 40 years old.

Willing to answer COVID-19 symptom questions

Willing to consent for 2 vision screening visits at baseline and 12-month follow-up

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Exclusion Criteria

You have self-reported that you have a terminal illness and are expected to live less than 1 year.

I am unable to understand or sign the consent form due to cognitive issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vision Screening

Vision screenings are provided to underserved New York City residents living in affordable housing buildings

5 years

Multiple visits as needed

Follow-up

Participants are monitored for adherence to follow-up eye exams and vision correction

1 year

Follow-up visits scheduled as needed

Treatment Details

Interventions

Enhanced Intervention Using Patient Navigators
Usual Care

Trial Overview The NYC-SIGHT study is testing if using patient navigators for follow-up improves eye health outcomes compared to usual care among underserved residents after a vision screening.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Enhanced InterventionActive Control1 Intervention

Consented subjects living in buildings randomized to the Patient Navigator Intervention arm who failed the screening and needed vision correction received free eyeglasses, which were fitted by an optician at the housing building. If they were referred to an ophthalmologist for a follow-up eye exam, they received enhanced support with patient navigators to assist with follow-up eye exams at Columbia Ophthalmology or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.

Group II: Usual CarePlacebo Group1 Intervention

Consented subjects living in buildings randomized to Usual Care arm who failed the screening and needed vision correction were given an eyeglasses prescription and a list of optical shops within 1 mile from their home. These subjects who are referred to an ophthalmologist for a follow-up eye exam were only scheduled for their initial appointment at either Columbia Ophthalmology or Harlem Hospital. They did not receive enhanced support. Scheduling this initial appointment allowed tracking of adherence.