- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06045390
An App-based Instructional Platform to Improve Eye Drop Recall
Assessing the Effects of an In-office, Language-concordant App on Eye Drop Recall in Patients With Multi-drop Regimens
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.
Study Overview
Detailed Description
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
- 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.
Study design
- Study design: Randomized study, two groups: (1) patients that use the app, and (2) patients that do not use the app.
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
- Intervention: Use of an in-office app that has both graphical and verbal (language-concordant) instruction for how to use drops.
- Main outcome measure: Ability to correctly identify drops/regimen
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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San Francisco, California, United States, 94110
- San Francisco General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
App features (App will be used during the office visit):
Other Names:
|
|
No Intervention: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage accuracy of drop regimen recall
Time Frame: 1 month follow up from time of intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall medication adherence, assessed through the modified Morisky Adherence Scale, a widely published scale for general medication adherence
Time Frame: 1 month follow up from time of intervention
|
An 8 question survey (7 questions are yes/no, with the final question on a Likert scale) gauging overall medication adherence.
Each question will be individually assessed (not summed into a cumulative score).
The higher number of "yes" responses corresponds to a lower adherence score.
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1 month follow up from time of intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frank Brodie, MD, UCSF, Department of Ophthalmology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-39908
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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