Glaucoma, Medication Adherence
Conditions
Keywords
iD2, Adherence, Medication, Glaucoma, Device
Brief summary
Most patients with glaucoma use eye drops to lower their intraocular pressure. However, poor adherence to prescribed eye drop regimens can lead to significant loss of vision-related quality of life. This study will test the iDrop Device (iD2), a device-on-cap electronic platform monitor designed to accurately track when a research participant removes an eye drop bottle cap, wirelessly communicate usage data to a database accessible to researchers, and send on-demand alerts when a medication is due. A device capable of tracking eye drop usage and sending dosage alerts will test the hypothesis that electronic reminders improve medication adherence and help research subjects improve their eye drop taking behavior. While our primary focus is on glaucoma adherence, this device could also benefit those with other chronic eye conditions requiring regular eye drop treatment, such as dry eye, corneal endothelial disease, eye infections, and uveitis.
Interventions
DEVICEEye drop cap monitor
Eye drop cap monitor for improving adherence
Sponsors
Universal Adherence LLC
National Eye Institute (NEI)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The trial includes 4 stages: Stage 1) a 30-day run-in period using the iD2 smart cap monitor without any reminders; Stage 2) a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window; Stage 3) A 45-day period in which all participants receive the reminders; and Stage 4) A 30-day period without any reminders.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Taking at least one glaucoma drop daily * A history of poor adherence when taking glaucoma eye drops. This is determined as an answer of 80% or less for the following question: "Over the past month, what percentage of your drops do you think you took correctly?" * Owns a functioning smart phone with Bluetooth and cellular connectivity
Exclusion criteria
* Advanced cognitive impairment * Current or expected pregnancy during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adherence when Using the Dose Monitor | 150 days | The iD2 device will track when the bottle cap is removed as a measure of medication adherence. Adherence will be measured throughout the study, comparing adherence when dose reminders are given against when no dose reminders are given. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction with the Dose Monitor | 150 days | A participant's satisfaction with the dose monitor is measured using a questionnaire administered during the last study visit. 8 questions will use a 1-5 Likert scale, with 1 corresponding to "Strongly Disagree" and 5 corresponding to "Strongly Agree" in response to statements regarding device satisfaction, such as "I would use this device again." 7 questions are open-ended. |
Contacts
CONTACTSteven Mansberger, MD, MPH
PRINCIPAL_INVESTIGATORSteven Mansberger, MD, MPH
U n i v e r s a l A d h e r e n c e , L L C
PRINCIPAL_INVESTIGATORRobert Kinast, MD
U n i v e r s a l A d h e r e n c e , L L C
PRINCIPAL_INVESTIGATORBrian Breiling, MS, BS
U n i v e r s a l A d h e r e n c e , L L C
PRINCIPAL_INVESTIGATORVince O'Malley
U n i v e r s a l A d h e r e n c e , L L C
Outcome results
None listed