Real-time Glaucoma Medication Adherence

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of real-time data collected on patients taking topical medication to treat glaucoma. Patients will be randomized to two groups, the first of which will only use the study device to take their medication, while the second will use the study device and receive on-demand reminder messages, when necessary.

Detailed Description
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Adherence to topical medications to treat glaucoma remains sub optimal; however, our understanding of this behavior remains limited due to biased measures of medication use. The Kali Drop device is a potential improvement in our ability to capture medication use in patients using dropper bottles by precisely capturing the amount dispensed in real-time. Moreover, such technology creates data that can be leveraged into driving behavior change using connected mobile technology in order to improve adherence and, ultimately, health outcomes. While evidence suggests that reminders may improve adherence to glaucoma medications, the power of doing so using real-time data has yet to be explored. This study will compare simple monitoring of patients to those who are being monitored and who receive reminder messages when the system determines one is necessary due to a missed dose.

Official Title
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Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Behavioral: Medication reminder
* Behavioral: Medication monitoring only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Glaucoma diagnosis Prescription for a prostaglandin indicated for glaucoma Nonadherent (MPR<80%) in the last 3 months according to pharmacy records Owns and operates a mobile phone and willing to receive periodic reminder messages Exclusion Criteria: Existing chronic eye condition in addition to glaucoma Scheduled for eye surgery in the next 90 days Prescription for a medication that will not fit in the device Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monitoring only<br>Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months | Behavioral: Medication monitoring only<br>* Patients will use an electronic medication monitoring device to record their actual medication use<br>|
| Experimental: Monitoring and reminder<br>Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months and will receive an automated reminder (text or voice) when a missed dose is determined by the device's system | Behavioral: Medication reminder<br>* Using the real-time data capture of the electronic device, an automated voice call or text message will be sent to active arm participants only when a missed dose is determined<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Changes and differences in adherence to glaucoma medication between groups | From study baseline through the 3 months of the intervention | 
| Adherence follow-up | Changes and differences in adherence to glaucoma medication between groups after the intervention | From study endpoint through the subsequent 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale | Differences in self-reported medication-related self-efficacy between groups | Change from baseline over the 3-month intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Mobile health, Real-time data