Know Your Pressures NYC

NCT05992415 | Not Yet Recruiting DMC

• 1 other identifier: ACYY0034
• Study Type: interventional
• Target: 7,085
• Locations: 1 country
• Sites: 1

Brief Summary

Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed "Know Your Pressures NYC" to conduct blood pressure (BP)/glaucoma screenings in adults age 40+ to identify undiagnosed and/or uncontrolled hypertension and/or glaucoma/suspect. For the purpose of this study, individuals will be identified as glaucoma suspects if they have elevated intraocular pressure (IOP) or have features of glaucoma optic neuropathy, as assessed by optical coherence tomography (OCT) and fundus/optic nerve photographs, as interpreted by the masked Reading Center.

Conditions

Glaucoma; Hypertension; Glaucoma, Suspect; Elevated Blood Pressure

Keywords

Blood pressure (BP); Intraocular pressure (IOP); Optic nerve imaging; Fundus photography; Blood pressure and glaucoma screening; Optical coherence tomography (OCT); Hypertension (HTN)

Outcome Measures

Primary Outcomes (2)

• Adherence to the Initial In-Office Appointment for those Referred to Ophthalmology and/or Primary Care (Implementation Outcome)

  The primary implementation outcome measure for Aim 1 is ADHERENCE TO INITIAL IN-OFFICE APPOINTMENT FOR THOSE REFERRED for follow-up and will be measured by attendance at the initial in-office appointment. The initial in-office appointment will be scheduled by the study team at the conclusion of the BP/glaucoma screening. A comparison will be made between participants living in the 10 developments randomized to the Virtual Automated Intervention Arm compared to 4 developments randomized to Usual Care Arm.

  1 year

• Detection of undiagnosed and/or uncontrolled hypertension and/or glaucoma/suspect for those Referred to follow-up confirmed by in-office eye exam (Clinical Effectiveness Outcome)

  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 exams and will calculate the proportion of referred participants who attend and are newly diagnosed and/or treated for uncontrolled HTN and/or glaucoma/suspect in the office over 1 year. Uncontrolled BP is defined as \>130/80 mmHg and uncontrolled glaucoma/suspect is defined as IOP \>24 including an abnormal optic nerve photograph or OCT image. We will compare the proportion of participants by arm with newly diagnosed and/or uncontrolled HTN and/or glaucoma/suspect in the office over 1 year. Participants who request their own eye doctor will be encouraged to make an appointment as soon as possible. These individuals will be excluded from the Outcome analysis for Aim 2.

  1 year

Secondary Outcomes (2)

• Follow-up Adherence to Recommended In-office Exams at 1-3 Years (Secondary Implementation Outcome)

  1-3 years

• Return Attendance at Blood Pressure/Glaucoma Screenings at 1-3 Years (Secondary Implementation Outcome)

  1-3 years

Study Arms (2)

Arm 1: Virtual Automated Navigator Intervention with Health Education

ACTIVE COMPARATOR

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.

Other: Virtual Automated Navigator Intervention with Health Education

Arm 2: Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Virtual Automated Navigator Intervention with Health Education OTHER

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 1: Virtual Automated Navigator Intervention with Health Education

Usual Care OTHER

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.

Arm 2: Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals age 40 and older.
• Living independently in an affordable housing development.
• Have a cell phone that can receive and send text messages (SMS).

You may not qualify if:

• Self-reported terminal illness with life expectancy less than 1 year.
• Inability to provide informed consent due to dementia or other reasons.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center - 622 W. 168th St. Floor 18

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Glaucoma; Hypertension; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lisa A. Hark

  Columbia University Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A. Hark, PhD, MBA

CONTACT

212-342-4586; lah112@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Ophthalmology Reading Center outcome assessors and investigators will interpret fundus/optic nerve photographs and OCT imaging and will be masked to participants' demographic and clinical information.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmic Sciences

Model Details: Know Your Pressures NYC is an innovative, type 2 hybrid effectiveness-implementation 2:1 cluster-randomized clinical trial (RCT) design enrolling individuals living in 14 NYCHA developments, home to 19,098 residents in Upper Manhattan. All participants referred for in-office follow-up exams will be scheduled for an initial appointment, followed by an RCT for those referred. Specific aims are guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 15, 2023
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)