Glaucoma, Medication Adherence
Conditions
Keywords
Adherence, Medication, Glaucoma, Device
Brief summary
Glaucoma is the second leading cause of visual impairment worldwide. Eye drop medications reduce vision loss from glaucoma by at least 60%, but eye drops must be taken every day to be effective. However, adherence to eye drop treatment is poor with only 50% of patients regularly taking their prescribed eye drops. The investigators are developing the Devers Drop Device (D3) eye drop monitor to accurately measure eye drop cap removal and to improve eye drop-taking behavior. The investigators will test eye drop adherence with the D3 device in a randomized, prospective clinical trial.
Detailed description
Universal Adherence is an emerging medical device company dedicated to improving adherence to ocular medications through innovative technical solutions. The Devers Drop Device (D3) will accurately track when a patient removes an eye drop bottle cap, communicate usage data wirelessly to a database that researchers can access, and send alerts to patients when a medication is due. In addition to helping patients maintain their dosing schedule, the D3 will also provide adherence information to researchers and eye care providers, which will help to understand poor treatment outcomes and to develop improved treatment strategies.The clinical benefits of the device in improving adherence will initially be assessed and targeted towards glaucoma, but the ability of the device to be attached to all FDA-approved eye drop bottle caps will make this device attractive to all patients that need consistent daily use of eye drops. Randomized, prospective clinical trial: The investigators will enroll 50 participants (25 male, 25 female) into a prospective trial with duration of up to 50 days. The inclusion criteria are those who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning Android or Apple iphone smartphone (iOs) with Bluetooth and cellular connectivity. The investigators will exclude patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire. The 50-day period is useful for glaucoma studies because patients revert to their normal dosing pattern within two weeks after their last visit. This study will include two stages: Stage 1) a 25-day period evaluating baseline patient adherence with the D3 device; and Stage 2) a subsequent 25-day period to determine the effect of no reminder versus daily reminder using the D3 app, which includes integrated audio and visual reminders.
Interventions
DEVICEDevers Drop Device (D3) app
A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
Sponsors
National Institutes of Health (NIH)
Oregon State University
National Eye Institute (NEI)
Universal Adherence LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning smartphone and have a password-protected home wireless connection.
Exclusion criteria
* Patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance Percentage | 50 days | Compliance percentage by dividing the number of days the dose monitor recorded dosing within 3 hours of the prescribed time by the number of days in the study cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 50 days | The investigators will also measure the participants' satisfaction with the dose monitor using a short Likert questionnaire. The questionnaire will include 5 questions. Each question will offer choices 1-5 with an overall minimum summed score of 5 and a maximum summed score of 25. Higher score will indicate higher satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control - no Reminder For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation. | 2 |
| Integrated Daily Reminder Using the D3 App For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device.
Devers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior. | 3 |
| Baseline Adherence Before randomizing subjects, all were given the device to observe if their adherence to their own medication was worse than 90% of the time. If so, they would enter the second stage and be placed in Group 1 or 2 | 45 |
| Total | 50 |
Baseline characteristics
| Characteristic | Control - no Reminder | Integrated Daily Reminder Using the D3 App | Baseline Adherence | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 33 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 12 Participants | 14 Participants |
| Age, Continuous | 73.5 years STANDARD_DEVIATION 6.36 | 64 years STANDARD_DEVIATION 8.88 | 68.13 years STANDARD_DEVIATION 11.17 | 67.8 years STANDARD_DEVIATION 8.75 |
| Race/Ethnicity, Customized African American | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 0 Participants | 0 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Caucasian | 0 Participants | 2 Participants | 35 Participants | 37 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 45 participants | 50 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 18 Participants | 21 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 27 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 | 1 / 50 |
| other Total, other adverse events | 1 / 2 | 0 / 3 | 1 / 50 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 | 0 / 50 |
Outcome results
Primary
Compliance Percentage
Compliance percentage by dividing the number of days the dose monitor recorded dosing within 3 hours of the prescribed time by the number of days in the study cycle
Time frame: 50 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - no Reminder | Compliance Percentage | 73.9 percentage of days dose monitor recorded | — |
| Integrated Daily Reminder Using the D3 App | Compliance Percentage | 94.6 percentage of days dose monitor recorded | Standard Deviation 7.6 |
| Baseline Adherence | Compliance Percentage | 93.99 percentage of days dose monitor recorded | Standard Deviation 16.2 |
Secondary
Patient Satisfaction
The investigators will also measure the participants' satisfaction with the dose monitor using a short Likert questionnaire. The questionnaire will include 5 questions. Each question will offer choices 1-5 with an overall minimum summed score of 5 and a maximum summed score of 25. Higher score will indicate higher satisfaction.
Time frame: 50 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - no Reminder | Patient Satisfaction | 17 scores on a scale | — |
| Integrated Daily Reminder Using the D3 App | Patient Satisfaction | 22.5 scores on a scale | Standard Deviation 2.1 |
| Baseline Adherence | Patient Satisfaction | 22.1 scores on a scale | Standard Deviation 3 |