N/A
Completed N=200
Improve Glaucoma Medication Adherence
Source: ClinicalTrials.gov NCT03052257 ↗Enrolled (actual)
200
Serious AEs
2.5%
Results posted
Aug 2020
Primary outcomePrimary: Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule — .84; 0.62 proportion of doses — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule |
.84; 0.62 | <0.0001 sig |
| SECONDARY VA Medical Resource Use and Costs |
10947; 12939 | — |
Eligibility Criteria
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 phone or landline phone.
Exclusion criteria for patients post randomization:
- Decision by patient and provider to cease glaucoma medication use
- Change in functional status such that the drops are no longer administered by the patient or the companion (such as nursing home care)
Data sourced from ClinicalTrials.gov (NCT03052257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.