Real-time Glaucoma Medication Adherence

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.

Full Title of Study: “Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 15, 2018

Detailed Description

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.

Interventions

  • Behavioral: Medication reminder
    • 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
  • Behavioral: Medication monitoring only
    • Patients will use an electronic medication monitoring device to record their actual medication use

Arms, Groups and Cohorts

  • Active Comparator: Monitoring only
    • Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months
  • Experimental: Monitoring and reminder
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Tennessee
  • Collaborator
    • Kali Care
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Justin Gatwood, PhD, Principal Investigator, University of Tennessee

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