An App-based Instructional Platform to Improve Eye Drop Recall

Glaucoma Clinical Trial

Official title:

Assessing the Effects of an In-office, Language-concordant App on Eye Drop Recall in Patients With Multi-drop Regimens

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06045390
• Other study ID #: 23-39908
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Sachin Patel, MD, PhD
• Phone: 415-353-2800
• Email: sachin.patel[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Glaucoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall medication adherence, assessed through the modified Morisky Adherence Scale, a widely published scale for general medication adherence	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.	1 month follow up from time of intervention