An App-based Instructional Platform to Improve Eye Drop Recall

NCT ID: NCT06045390

Last Updated: 2025-12-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-06-01

Brief Summary

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The goal of this interventional study is to assess whether an in-office, language-concordant instructional app improves drop regimen recall in a population of glaucoma patients who are on multi-drop regimens.

Participants will be divided into two groups -- those who use the app and those who do not. The app will have narrated information regarding the drop regimen, a quiz to test understanding of the regimen, and will enable a graphical printout of the eye drops and schedule.

At one month, both groups will be assessed on their eye drop regimen recall.

Detailed Description

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Specific Aim: To investigate whether a language-concordant instructional application improves drop regimen recall in population of glaucoma patients at a 1-month follow-up period.

App features

1. Pictorial representation of drops (color-coded) and schedule.
2. Quiz to assess understanding of the regimen.
3. Narrated instructions (language-concordant) on how and when (frequency and eye laterality) to take each drop.
4. Graphical print-out of the regimen.

Study design

1. Study design: Randomized study, two groups: (1) patients that use the app, and (2) patients that do not use the app.
2. Study population:

Inclusion criteria: patients with primary open-angle glaucoma on at least 2 eye drops

Exclusion criteria: patients taking additional prescribed eye drops for other eye conditions; patients diagnosed within the last 3 months; patients unable to self-administer eye drops
3. Intervention: Use of an in-office app that has both graphical and verbal (language-concordant) instruction for how to use drops.
4. Main outcome measure: Ability to correctly identify drops/regimen

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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App arm

The intervention is an in-office app that contains graphical and narrated information on a patient's specific drop regimen, and includes a quiz and a graphical print-out of their drop schedule. The patient will use the app during their clinic visit.

Group Type EXPERIMENTAL

App

Intervention Type OTHER

App features (App will be used during the office visit):

* Pictorial representation of drops (color-coded) and schedule.
* Quiz to assess understanding of the regimen.
* Narrated instructions (language-concordant) on how and when (frequency and eye laterality) to take each drop.
* Graphical print-out of the regimen.

Standard arm

The standard arm will be the standard of care, which involves a provider explanation of their drop regimen (using a phone interpreter if needed).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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App

App features (App will be used during the office visit):

* Pictorial representation of drops (color-coded) and schedule.
* Quiz to assess understanding of the regimen.
* Narrated instructions (language-concordant) on how and when (frequency and eye laterality) to take each drop.
* Graphical print-out of the regimen.

Intervention Type OTHER

Other Intervention Names

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App-based drop instructions

Eligibility Criteria

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Inclusion Criteria

* patients with a diagnosis of glaucoma (any type)
* drop regimen of at least 2 pressure-lowering drops
* languages supported at this time: English, Spanish, Cantonese

Exclusion Criteria

* concurrent eye conditions necessitating additional eye drops
* inability to self-administer eye drops
* inability to engage with app (either visual or other barrier)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Brodie, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF, Department of Ophthalmology

Locations

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San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

References

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Newman-Casey PA, Blachley T, Lee PP, Heisler M, Farris KB, Stein JD. Patterns of Glaucoma Medication Adherence over Four Years of Follow-Up. Ophthalmology. 2015 Oct;122(10):2010-21. doi: 10.1016/j.ophtha.2015.06.039. Epub 2015 Aug 25.

Reference Type BACKGROUND
PMID: 26319441 (View on PubMed)

Zolnierek KB, Dimatteo MR. Physician communication and patient adherence to treatment: a meta-analysis. Med Care. 2009 Aug;47(8):826-34. doi: 10.1097/MLR.0b013e31819a5acc.

Reference Type BACKGROUND
PMID: 19584762 (View on PubMed)

Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24.

Reference Type BACKGROUND
PMID: 25912144 (View on PubMed)

Other Identifiers

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23-39908

Identifier Type: -

Identifier Source: org_study_id