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An App-based Instructional Platform to Improve Eye Drop Recall

Primary Purpose

Glaucoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

App arm

Standard arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT06045390
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
App arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard arm
Arm Type
No Intervention
Arm Description
The standard arm will be the standard of care, which involves a provider explanation of their drop regimen (using a phone interpreter if needed).
Intervention Type
Other
Intervention Name(s)
App
Other Intervention Name(s)
App-based drop instructions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage accuracy of drop regimen recall
Description
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.
Time Frame
1 month follow up from time of intervention
Secondary Outcome Measure Information:
Title
Overall medication adherence, assessed through the modified Morisky Adherence Scale, a widely published scale for general medication adherence
Description
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.
Time Frame
1 month follow up from time of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin Patel, MD, PhD
Phone
415-353-2800
Email
sachin.patel@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Brodie, MD
Phone
415-353-2800
Email
frank.brodie@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Brodie, MD
Organizational Affiliation
UCSF, Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Patel, MD, PhD
Phone
628-206-8000
Email
sachin.patel@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26319441
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.
Results Reference
background
PubMed Identifier
19584762
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.
Results Reference
background
PubMed Identifier
25912144
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.
Results Reference
background

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An App-based Instructional Platform to Improve Eye Drop Recall

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