Real-time Glaucoma Medication Adherence

Not Applicable

Terminated

• Conditions: Glaucoma
• Interventions: Behavioral: Medication monitoring only; Behavioral: Medication reminder

• Registration Number: NCT03194828
• Lead Sponsor: University of Tennessee

Brief Summary

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

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 Timeline

• Status Verified: 2017-05
• Study Start: 2017-05-08
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-21
• Primary Completion: 2018-07-15
• Study Completion: 2018-07-15
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitoring only	Medication 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
Monitoring and reminder	Medication 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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Barney's Pharmacy; 🇺🇸 Louisville, Georgia, United States

Hutton Pharmacy; 🇺🇸 Blackwell, Oklahoma, United States

Creative Care Pharmacy; 🇺🇸 Edmond, Oklahoma, United States

Mustang Drug; 🇺🇸 Mustang, Oklahoma, United States

University of Tennessee College of Pharmacy; 🇺🇸 Nashville, Tennessee, United States