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Clinical Trials/NCT03194828
NCT03194828TerminatedNot Applicable

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

University of Tennessee8 sites in 1 country5 target enrollmentStarted: May 8, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
8
Primary Endpoint
Adherence follow-up

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Monitoring only

Active Comparator

Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months

Intervention: Medication monitoring only (Behavioral)

Monitoring and reminder

Experimental

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

Intervention: Medication reminder (Behavioral)

Outcomes

Primary Outcomes

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

Adherence

Time Frame: From study baseline through the 3 months of the intervention

Changes and differences in adherence to glaucoma medication between groups

Secondary Outcomes

  • Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale(Change from baseline over the 3-month intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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