Clinical trial NCT06045390: An App-based Instructional Platform to Improve Eye Drop Recall
Official title: Assessing the Effects of an In-office, Language-concordant App on Eye Drop Recall in Patients With Multi-drop Regimens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

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

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage accuracy of drop regimen recall
timeFrame: 1 month follow up from time of intervention
Secondary outcomes:
measure: Overall medication adherence, assessed through the modified Morisky Adherence Scale, a widely published scale for general medication adherence
timeFrame: 1 month follow up from time of intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: UCSF, Department of Ophthalmology
name: Frank Brodie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.