Real-time Glaucoma Medication Adherence

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

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Behavioral: Medication monitoring only; Behavioral: Medication reminder

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30906
      • Barney's Pharmacy
    • Augusta, Georgia, United States, 30907
      • Barney's Pharmacy
    • Grovetown, Georgia, United States, 30813
      • Barney's Pharmacy
    • Louisville, Georgia, United States, 30434
      • Barney's Pharmacy
  • Oklahoma
    • Blackwell, Oklahoma, United States, 74631
      • Hutton Pharmacy
    • Edmond, Oklahoma, United States, 73013
      • Creative Care Pharmacy
    • Mustang, Oklahoma, United States, 73064
      • Mustang Drug
  • Tennessee
    • Nashville, Tennessee, United States, 37210
      • University of Tennessee College of Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: Medication monitoring only; Patients will use an electronic medication monitoring device to record their actual medication use
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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: Kali Care; Barney's Pharmacy; Creative Care Pharmacy; Hutton Pharmacy; Mustang Drug
• Investigators: Principal Investigator: Justin Gatwood, PhD, University of Tennessee

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): July 15, 2018
• Study Completion (Actual): July 15, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Adherence; Mobile health; Real-time data
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 17-05074-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No