Clinical trial NCT03194828: Real-time Glaucoma Medication Adherence
Official title: Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Keywords: Adherence
Mobile health
Real-time data
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Kali Care
name: Barney's Pharmacy
name: Creative Care Pharmacy
name: Hutton Pharmacy
name: Mustang Drug
First posted: 2017-06-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: From study baseline through the 3 months of the intervention
measure: Adherence follow-up
timeFrame: From study endpoint through the subsequent 3 months
Secondary outcomes:
measure: Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale
timeFrame: Change from baseline over the 3-month intervention
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Barney's Pharmacy
state: Georgia
city: Augusta
country: United States
facility: Barney's Pharmacy
state: Georgia
city: Grovetown
country: United States
facility: Barney's Pharmacy
state: Georgia
city: Louisville
country: United States
facility: Barney's Pharmacy
state: Georgia
city: Blackwell
country: United States
facility: Hutton Pharmacy
state: Oklahoma
city: Edmond
country: United States
facility: Creative Care Pharmacy
state: Oklahoma
city: Mustang
country: United States
facility: Mustang Drug
state: Oklahoma
city: Nashville
country: United States
facility: University of Tennessee College of Pharmacy
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Justin Gatwood, PhD
role: PRINCIPAL_INVESTIGATOR
References: