Real-time Glaucoma Medication Adherence

N/ATerminatedNCT03194828

University of Tennessee5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Glaucoma

Interventions

Medication reminderBEHAVIORAL

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

Medication monitoring onlyBEHAVIORAL

Patients will use an electronic medication monitoring device to record their actual medication use

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Barney's Pharmacy

Augusta, Georgia, United States

Barney's Pharmacy

Augusta, Georgia, United States

Barney's Pharmacy

Grovetown, Georgia, United States

Barney's Pharmacy

Louisville, Georgia, United States

Outcomes

Primary Outcomes

Adherence

Changes and differences in adherence to glaucoma medication between groups

Time frame: 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

Time frame: From study endpoint through the subsequent 3 months

Secondary Outcomes

Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale

Differences in self-reported medication-related self-efficacy between groups

Time frame: Change from baseline over the 3-month intervention

Data from ClinicalTrials.gov

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