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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
Must not have
Inability to provide informed consent due to dementia or other reasons
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand and give consent for treatment due to dementia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to Follow-up Eye Care
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 at either Columbia Harkness Eye Institute or Harlem Hospital Ophthalmology, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
Group II: Arm 2: Usual Care + Automated Appointment RemindersPlacebo Group1 Intervention
Consented participants referred from the 5 developments randomized to the Usual Care Arm +Automated Appointment Reminders who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Columbia Harkness Eye Institute or Harlem Hospital Ophthalmology. 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
1,486 Previous Clinical Trials
2,653,180 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 + Automated Appointment Reminders
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.
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