CompletedNot Applicable

Improve Glaucoma Medication Adherence

United States200 participantsStarted 2017-08-09

Plain-language summary

The proposed study is a randomized controlled trial enrolling Veterans with medically treated glaucoma who report less than 100% adherence to the prescribed glaucoma therapy. Participants will be randomized to receive either a one-on-one session with a member of the research team discussing the disease process and strategies for administering eye drops (intervention) or a one-on-one session with a member of the research team discussing general eye health (control). All participants will be provided with a "smart bottle" to house their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder function will be activated. The proportion or prescribed doses taken according to the monitor will be compared for the two groups.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of open angle glaucoma \[primary open angle glaucoma, pigment dispersion glaucoma, pseudoexfoliation glaucoma, combined mechanism glaucoma, low tension glaucoma\] recorded in the medical record * Prescribed glaucoma eye drops, * Visual field performed within the last 9 months. * As visual field testing is standard care glaucoma and the investigators wish to establish baseline glaucoma severity, the investigators will require that subjects have a visual field test documented in the chart within 9 months of enrollment. Exclusion Criteria: Exclusion criteria for patients At Screener: * "How confident are you that you always remember to use your glaucoma medications?" * not at all confident * somewhat confident * very confident) * And "In the past 4 weeks, did you ever forget to take your medicine?" * Veterans who respond both "very confident" and "no", respectively, will be excluded Inclusion criteria for companions at screener: * Willing to participate in assisting the patient with glaucoma drops and * Willing to accompany the patient to the intervention visit for participants in the intervention arm or eye health education visit for participants in the control arm. Exclusion criteria for companions: Unable or unwilling to attend baseline visit and intervention or control arm educational session with patient participant. Exclusion criteria for patients or companions: * Lacks proficiency in English, * Lacks either a cell phon…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule

Timeframe: Randomization to 6 Months

Trial details

NCT IDNCT03052257

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2019-08-01

Results submitted2020-07-29

View on ClinicalTrials.gov More Glaucoma trials