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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special app can help glaucoma patients better remember their eye drop schedules. Glaucoma, an eye condition that can lead to vision loss, often requires using multiple eye drops daily. Participants will either use the app, which includes narrated instructions and a quiz, or follow standard doctor instructions. Eligible patients have glaucoma, use at least two eye drops to lower eye pressure, and can speak English, Spanish, or Cantonese. The trial aims to determine if the app improves patients' recall of their drop regimen after a month. As an unphased trial, this study offers patients the chance to contribute to innovative solutions for managing glaucoma.

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 prior data suggests that this app is safe for use in glaucoma patients?

Research shows that apps designed to help people remember their glaucoma medication have been popular with users. For instance, one study found that a similar app was well-liked by users who tracked their daily medication for two months. However, specific safety data for this exact app is not available. Since the app involves no physical procedures and only provides information, it is generally considered safe. This study focuses on how well the app aids patients in remembering to take their medication, not on testing its safety, so any risks are likely very low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the App for Glaucoma Medication Recall because it offers a fresh approach to helping patients manage their medication schedules. Unlike the traditional method where healthcare providers verbally explain eye drop regimens, this app provides patients with graphical and narrated information tailored to their specific needs. It includes interactive features like quizzes to reinforce understanding and a printed schedule to take home. This innovative method aims to enhance patient recall and adherence, potentially improving the effectiveness of glaucoma management.

What evidence suggests that this app is effective for improving glaucoma medication recall?

Research has shown that apps can significantly aid people in remembering to take their medications. In a previous study, a similar app helped users remember their medications 97.2% of the time, outperforming traditional methods. In this trial, one group of participants will use an app specifically designed to assist glaucoma patients in remembering to use their eye drops. The app employs spoken instructions, quizzes, and pictures to help patients understand and follow their treatment plans. Studies indicate that tools like this can enhance medication management, potentially leading to improved health. ^{3 5 6 7 8}

Who Is on the Research Team?

Frank Brodie, MD

Principal Investigator

UCSF, Department of Ophthalmology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00056-9/fulltext

Deep Learning–Driven Glaucoma Medication Bottle ... Results. The CNN-based mobile app achieved a mean average precision of 98.8% and recall of 97.2%. Identification accuracy significantly improved from 27.6% ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525000569

A Multilingual Clinical Validation Study in Patients with ... The CNN-based mobile app significantly improves medication identification accuracy in patients with glaucomatous vision loss without increasing the time to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8517037/

Review of glaucoma medication adherence monitoring in ... Patient adherence to glaucoma medications is often low. Recent innovations in digital sensor technologies have been leveraged to confirm eyedrop ...

4. withpower.com withpower.com/trial/phase-glaucoma-9-2023-493d2

App for Glaucoma Medication Recall 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 ...

5. avehjournal.org avehjournal.org/index.php/aveh/article/view/938/2790

and long-term effectiveness of interventions for improving ... The study aims to assess the effectiveness of short- and long-term behavioural, educational and mixed interventions for improving adherence to glaucoma ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589419621001848

Fast and Accurate Ophthalmic Medication Bottle ... We have retrained MobileNet V2 to accurately identify ophthalmic medication bottles and demonstrated that this neural network can operate in a smartphone ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930135/

Artificial Intelligence Models to Identify Patients with High ... In this large nationwide multicenter study, we developed AI prediction algorithms to identify patients who have a high probability of glaucoma, using ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11416277/

Is CONNECTDROP®, a Medication Event Monitoring ... In this pilot study, the CONNECTDROP device was able to monitor daily intake of anti-glaucomatous medication over 2 months and had high satisfaction amongst ...