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Behavioural Intervention
Patient Navigator Intervention for Vision Impairment or Blindness (NYCES Trial)
N/A
Waitlist Available
Led By Lisa A. Hark
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals age 21 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
NYCES Trial Summary
This trial aims to improve eye health for adults in New York City by addressing disparities in eye care access & outcomes. #EyeHealth #EyeEquity
Who is the study for?
The NYC Eye Study is for adults aged 21+ living independently in certain affordable housing areas. It's aimed at those with eye conditions like blindness, cataract, diabetic retinopathy, and glaucoma. People with terminal illnesses or unable to consent due to dementia cannot participate.Check my eligibility
What is being tested?
This study tests whether using patient navigators can improve eye health compared to usual care without them. Patient navigators are people who help guide patients through the healthcare system to ensure they receive appropriate care.See study design
What are the potential side effects?
Since this trial involves non-medical interventions (patient navigators), there aren't typical medication side effects. However, participants may experience stress or anxiety from additional appointments or changes in their routine.
NYCES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
NYCES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to Follow-up Eye Care
NYCES Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Arm 1: Intervention Using Patient NavigatorsActive Control1 Intervention
Consented participants referred to ophthalmology from the 9 developments randomized to the Intervention Arm will receive ongoing support from patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
Group II: Arm 2: Usual Care Without Patient NavigatorsPlacebo Group1 Intervention
Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1-year period.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,450,833 Total Patients Enrolled
1 Trials studying Cataract
749 Patients Enrolled for Cataract
Lisa A. HarkPrincipal InvestigatorColumbia University Department of Ophthalmology
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and give consent for treatment due to dementia.You have a terminal illness and are expected to live less than 1 year.I am 21 years old or older.This criterion means that the participant must be living on their own in a housing area that is not too expensive.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Intervention Using Patient Navigators
- Group 2: Arm 2: Usual Care Without Patient Navigators
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for participants to join this trial currently?
"Per the information on clinicaltrials.gov, this trial has concluded its recruitment process. The study first appeared on July 1st 2024 and was last modified August 7th 2023; however, there are currently 371 other studies seeking participants."
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