Know Your Pressures NYC

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals age 40 and older.

Living independently in an affordable housing development.

Have a cell phone that can receive and send text messages (SMS).

Disqualifiers

Self-reported terminal illness with life expectancy less than 1 year.

Inability to provide informed consent due to dementia or other reasons.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Automated Navigator Intervention with Health Education

    Other intervention

    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

    Other intervention

    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.

Treatment groups

7,085 Participants
are divided into 2 treatment groups
Group A: Arm 1: Virtual Automated Navigator Intervention with Health EducationActive comparator 1 intervention
Group B: Arm 2: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1-3 years
2

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.

Time frame
1-3 years

Other outcomes

Sponsors and contacts

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