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An App-based Instructional Platform to Improve Eye Drop Recall

Sponsor
University of California, San Francisco (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06045390
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
7.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: App
 N/A

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

  1. Intervention: Use of an in-office app that has both graphical and verbal (language-concordant) instruction for how to use drops.

  2. Main outcome measure: Ability to correctly identify drops/regimen

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Assessing the Effects of an In-office, Language-concordant App on Eye Drop Recall in Patients With Multi-drop Regimens
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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.

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.
Other Names:
  • App-based drop instructions

    		•
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Percentage accuracy of drop regimen recall [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.

    Secondary Outcome Measures

    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]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Francisco General Hospital San Francisco California United States 94110

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Frank Brodie, MD, UCSF, Department of Ophthalmology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT06045390
    Other Study ID Numbers:
    • 23-39908
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Sep 21, 2023