NCT06045390

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

September 13, 2023

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage accuracy of drop regimen recall

    This will be assessed through questions querying which drops the patients are taking, the number of times they are taking each drop, and the laterality of each drop. Each answer/drop will be individual recorded, and then total number of correct answers will be divided by the total number of questions.

    1 month follow up from time of intervention

Secondary Outcomes (1)

  • Overall medication adherence, assessed through the modified Morisky Adherence Scale, a widely published scale for general medication adherence

    1 month follow up from time of intervention

Study Arms (2)

App arm

EXPERIMENTAL

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.

Other: App

Standard arm

NO INTERVENTION

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

Interventions

AppOTHER

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.

Also known as: App-based drop instructions
App arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (3)

  • 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.

    PMID: 26319441BACKGROUND
  • 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.

    PMID: 19584762BACKGROUND
  • 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.

    PMID: 25912144BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Frank Brodie, MD

    UCSF, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

September 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations