App for Glaucoma Medication Recall

Overseen By Frank Brodie, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Pressure-lowering drops

Disqualifiers: Concurrent eye conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. However, since the study focuses on improving recall of your existing eye drop regimen, it seems likely that you will continue your current medications.

What data supports the effectiveness of the App for Glaucoma Medication Recall treatment?

The EyePhone© App, a similar reminder application, was found to be useful in improving adherence to medical treatment among glaucoma patients, suggesting that reminder apps can help patients remember to take their medication. ^{1 2 3 4 5}

Is the app for glaucoma medication recall safe for humans?

The research articles do not provide specific safety data for the app used in glaucoma medication recall. They discuss apps for reporting adverse events and improving drug safety communication, but not the safety of the app itself. ^{6 7 8 9 10}

How is the App for Glaucoma Medication Recall different from other treatments for glaucoma?

The App for Glaucoma Medication Recall is unique because it is a smartphone-based reminder application specifically designed to improve adherence to glaucoma therapy, addressing the common issue of patients forgetting to take their medication. ^{1 2 4 11 12}

Research Team

Frank Brodie, MD

Principal Investigator

UCSF, Department of Ophthalmology

Eligibility Criteria

This trial is for glaucoma patients who manage their condition with at least two pressure-lowering eye drops and can communicate in English, Spanish, or Cantonese. It's not suitable for those who can't use eye drops by themselves or have trouble interacting with an app due to visual or other barriers.

Inclusion Criteria

I have been diagnosed with glaucoma.

This service currently supports English, Spanish and Cantonese.

I use at least 2 types of eye drops to lower eye pressure.

Exclusion Criteria

I cannot put in my own eye drops.

Inability to engage with app (either visual or other barrier)

I need extra eye drops for another eye condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are divided into two groups: one using the app and one receiving standard care. The app provides graphical and narrated instructions on eye drop regimens.

1 month

1 visit (in-person)

Follow-up

Participants are assessed on their eye drop regimen recall and overall medication adherence using the modified Morisky Adherence Scale.

1 month

1 visit (in-person)

Treatment Details

Interventions

• App

Trial Overview The study tests if a special instructional app helps people remember how and when to take their glaucoma eye drops better than without the app. Participants will be split into two groups: one using the app and one not, then checked after a month on how well they recall their drop schedule.

Participant Groups

Group I: App arm Experimental Treatment 1 Intervention

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.

Group II: Standard arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Findings from Research

AdEPro is an interactive app designed to simplify the exploration of adverse event data from clinical trials, allowing users to visualize data on individual subjects and treatment groups without needing extensive programming skills.

The app serves as a 'hypothesis generator' for users to quickly investigate questions about adverse events, such as their onset and severity, while ensuring that patient data is processed locally for privacy and security.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. Mentenich, N., Tasto, C., Becker, B.[2021]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

A study analyzing 20 commonly prescribed oral medications across seven drug information mobile applications found significant variations in how adverse drug reaction (ADR) information is presented, which could affect clinical decision-making.

Key differences included the presence of placebo comparisons, with Lexicomp providing this information 30% of the time, while other apps lacked it; also, while most databases used quantitative formatting for ADRs, Epocrates did not, highlighting the need for careful selection of DI applications by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of adverse drug reaction formatting in drug information mobile phone applications. McConachie, SM., Berri, D., Konja, J., et al.[2022]

The VACC-Tool 2.0 mobile application significantly improved the classification of neuroinflammatory adverse events (NIAE) in children, successfully identifying 69% of cases that were missed or incorrectly coded in emergency department reports.

By using the VACC-Tool for longitudinal follow-up, additional NIAE were identified, demonstrating its effectiveness in enhancing the quality of safety information for pharmacovigilance and ensuring compliance with regulatory data standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study. Hoppe, C., Obermeier, P., Muehlhans, S., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Systemic Barriers in Receiving Electronically Prescribed Glaucoma Medications. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of the After-visit Summary in Medication Recall Among Glaucoma Patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of a medication alarm device on patient compliance with topical pilocarpine. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

A novel EyePhone© App for improving adherence to glaucoma therapy. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A prototype protocol for evaluating the real-world data set using a structured electronic health record in glaucoma. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of adverse drug reaction formatting in drug information mobile phone applications. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

The Wills Eye Glaucoma App: Interest of Patients and Their Caregivers in a Smartphone-based and Tablet-based Glaucoma Application. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Electronic monitoring to assess adherence with once-daily glaucoma medications and risk factors for nonadherence: the automated dosing reminder study. [2015]