GlaucomaNCT05992415
Know Your Pressures NYC
A study testing Virtual Automated Navigator Intervention with Health Education in people with Glaucoma and Hypertension, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Hypertension, Glaucoma, Suspect
- What is being tested?
- Virtual Automated Navigator Intervention with Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,085 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals age 40 and older.
- Living independently in an affordable housing development.
- Have a cell phone that can receive and send text messages (SMS).
Who cannot join
- Self-reported terminal illness with life expectancy less than 1 year.
- Inability to provide informed consent due to dementia or other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Irving Medical Center - 622 W. 168th St. Floor 18
New York, New York, 10032
Lisa A. Hark, PhD, MBA, 212-342-4586, lah112@cumc.columbia.edu
About this study
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.
Read the detailed description
Led by Dr. Lisa A. Hark, with support from an interdisciplinary team with experience in ophthalmology, preventive cardiology, primary care, nursing, biostatistics, implementation science, mixed-methods epidemiology, and informatics, 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.
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.
- The primary Implementation outcome measure for Aim 2 is adherence to in-office appointments for those referred for follow-up.
- 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
- Glaucoma, Hypertension, Glaucoma, Suspect, Elevated Blood Pressure
- Being tested
- Virtual Automated Navigator Intervention with Health Education, Usual Care
- Keywords
- Blood pressure (BP), Intraocular pressure (IOP), Optic nerve imaging, Fundus photography, Blood pressure and glaucoma screening, Optical coherence tomography (OCT), Hypertension (HTN)
- Medical subject headings
- Glaucoma, Hypertension, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Automated Navigator Intervention with Health EducationOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
Follow-up Adherence to Recommended In-office Exams at 1-3 Years (Secondary Implementation Outcome)
A secondary maintenance measure is follow-up adherence to recommended in-office appointments for those who are referred and attend the initial appointment to assess access to care sustainability at 1-4 years. Adherence will be assessed annually on the basis of the expected follow-up schedule defined at the index visit for that year if the participant attends. In the first year, the follow-up recommendation given by the primary care provider and/or the ophthalmologist will be classified into 1 of 4 categories: return within 2 months, return in 3 to 4 months, return in 6 months, or return in 12 months. This follow-up recommendation will be translated into the corresponding expected number of visits per year: 6, 3, 2, or 1.
Measured: 1-3 years
Return Attendance at Blood Pressure/Glaucoma Screenings at 1-3 Years (Secondary Implementation Outcome)
All participants will be invited to return to the BP/eye health screenings at 1, 2, and 3-year follow-up intervals to repeat the BP/glaucoma screening. We hypothesize that participants will return at various intervals (1, 2, and/or 3 times) and we want to understand the demographics and clinical characteristics of these participants as well as the frequency of attendance and why they returned and compare to those who did not elect to participate again. The intervals will be 1,2, and 3 years and we will measure the number and percentage of participants who attend the screenings over 4 years.
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 7,085 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Hark, PhD, MBA, Columbia University
- Investigators
- Lisa A. Hark, Principal investigator, Columbia University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992415
- Sponsor's protocol ID
- ACYY0034
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Know Your Pressures NYC
- ClinicalTrials.gov ID
- NCT05992415
- Acronym / sponsor ID
- ACYY0034
- 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)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,085 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Led by Dr. Lisa A. Hark, with support from an interdisciplinary team with experience in ophthalmology, preventive cardiology, primary care, nursing, biostatistics, implementation science, mixed-methods epidemiology, and informatics, 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.
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.
- The primary Implementation outcome measure for Aim 2 is adherence to in-office appointments for those referred for follow-up.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Virtual Automated Navigator Intervention with Health Education | Active comparator | Other: Virtual Automated Navigator Intervention with Health EducationConsented 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. |
| Arm 2: Usual Care | Active comparator | Other: Usual CareConsented 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals age 40 and older.
- Living independently in an affordable housing development.
- Have a cell phone that can receive and send text messages (SMS).
Key exclusion criteria (2 listed)
- Self-reported terminal illness with life expectancy less than 1 year.
- Inability to provide informed consent due to dementia or other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Automated Navigator Intervention with Health EducationConsented 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. | Other | Arm 1: Virtual Automated Navigator Intervention with Health Education |
| Usual CareConsented 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. | Other | Arm 2: Usual Care |
Primary outcome
Adherence to the Initial In-Office Appointment for those Referred to Ophthalmology and/or Primary Care (Implementation Outcome)
Time frame: 1 year
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.
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)
Time frame: 1 year
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.
2 secondary outcomes
Follow-up Adherence to Recommended In-office Exams at 1-3 Years (Secondary Implementation Outcome)
Time frame: 1-3 years
Return Attendance at Blood Pressure/Glaucoma Screenings at 1-3 Years (Secondary Implementation Outcome)
Time frame: 1-3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa A. Hark principal investigator
Columbia University Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Automated Navigator Intervention with Health Education in people with Glaucoma and Hypertension, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa A. Hark, PhD, MBA (212-342-4586, lah112@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Initial In-Office Appointment for those Referred to Ophthalmology and/or Primary Care (Implementation Outcome) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.