Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
7085 participants
INTERVENTIONAL
2026-07-01
2031-06-30
Brief Summary
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Detailed Description
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Aim 1: Conduct combined blood pressure (BP) and glaucoma screenings, and subsequent referrals, among adults age 40+ living in NYC affordable housing developments over 4 years.
Estimation: We will estimate, within a 4% margin of error, the detection rates of undiagnosed and/or uncontrolled HTN and/or glaucoma/suspect by assessing BP, IOP, visual acuity, and optic nerve imaging (OCT and fundus photography).
Aim 2: Evaluate the effectiveness of a Virtual Automated Navigator Intervention with Health Education on appointment adherence in participants referred for follow-up in-office exams after BP/glaucoma screenings compared to Usual Care.
1. The primary Implementation outcome measure for Aim 2 is adherence to in-office appointments for those referred for follow-up.
2. The primary clinical effectiveness outcome measure for Aim 2 is detection of undiagnosed and/or uncontrolled HTN and/or glaucoma/suspect confirmed by in-office appointment(s) and will be measured by rates of newly diagnosed and/or uncontrolled cases of HTN and/or glaucoma/suspect in the office over 1 year.
Hypothesis: Participants referred and randomized to the Virtual Automated Navigator Intervention with Health Education Arm will show higher rates of adherence to in-office appointments over 1 year compared to those receiving Usual Care, who will only receive the initial appointment.
Aim 3: Using RE-AIM, assess Reach, Adoption, Implementation, Maintenance and Sustainability at 1-4 years using a mixed-methods study for those screened and referred.
Hypothesis: Assessing implementation outcomes about Reach (% eligible who are screened); Adoption (% screened who require follow-up); and Maintenance (% returning in 1-year) will inform future interventions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Arm 1: Virtual Automated Navigator Intervention with Health Education
Consented participants referred for follow-up to in-office appointments from the 10 NYCHA developments randomized to the Virtual Automated Navigator Intervention with Health Education Arm will receive text messaging support with all aspects of follow-up appointments at either Columbia University Irving Medical Center or Harlem Hospital, specifically appointment scheduling and education about hypertension and/or glaucoma/suspect over a 1 year period.
Virtual Automated Navigator Intervention with Health Education
Consented participants referred for follow-up to in-office appointments from the 10 developments randomized to the Virtual Automated Navigator Intervention with Health Education Arm will receive text messaging support via REDCAP with all aspects of follow-up appointments at either Columbia University Irving Medical Center or Harlem Hospital, specifically appointment scheduling and education about hypertension and/or glaucoma/suspect over a 1 year period.
Arm 2: Usual Care
Consented participants referred for follow-up to in-office appointments from the 4 NYCHA developments randomized to the Usual Care Arm will only be scheduled for their initial appointments at either Columbia University Irving Medical Center 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.
Usual Care
Consented participants referred for follow-up to in-office appointments from the 4 developments randomized to the Usual Care Arm will only be scheduled for their initial appointments at either Columbia University Irving Medical Center 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.
Interventions
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Virtual Automated Navigator Intervention with Health Education
Consented participants referred for follow-up to in-office appointments from the 10 developments randomized to the Virtual Automated Navigator Intervention with Health Education Arm will receive text messaging support via REDCAP with all aspects of follow-up appointments at either Columbia University Irving Medical Center or Harlem Hospital, specifically appointment scheduling and education about hypertension and/or glaucoma/suspect over a 1 year period.
Usual Care
Consented participants referred for follow-up to in-office appointments from the 4 developments randomized to the Usual Care Arm will only be scheduled for their initial appointments at either Columbia University Irving Medical Center 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.
Eligibility Criteria
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Inclusion Criteria
* Living independently in an affordable housing development.
* Have a cell phone that can receive and send text messages (SMS).
Exclusion Criteria
* Inability to provide informed consent due to dementia or other reasons.
40 Years
ALL
Yes
Sponsors
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Columbia University
OTHER
Responsible Party
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Lisa Hark, PhD, MBA
Professor of Ophthalmic Sciences
Principal Investigators
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Lisa A. Hark
Role: PRINCIPAL_INVESTIGATOR
Columbia University Department of Ophthalmology
Locations
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Columbia University Irving Medical Center - 622 W. 168th St. Floor 18
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ACYY0034
Identifier Type: -
Identifier Source: org_study_id
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