Real-time Glaucoma Medication Adherence

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03194828
• Other study ID #: 17-05074-XP
• Status: Terminated
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: May 2017
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	Barney's Pharmacy	Augusta	Georgia
United States	Barney's Pharmacy	Augusta	Georgia
United States	Hutton Pharmacy	Blackwell	Oklahoma
United States	Creative Care Pharmacy	Edmond	Oklahoma
United States	Barney's Pharmacy	Grovetown	Georgia
United States	Barney's Pharmacy	Louisville	Georgia
United States	Mustang Drug	Mustang	Oklahoma
United States	University of Tennessee College of Pharmacy	Nashville	Tennessee

Sponsors (6)

Lead Sponsor	Collaborator
University of Tennessee	Barney's Pharmacy, Creative Care Pharmacy, Hutton Pharmacy, Kali Care, Mustang Drug

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Changes and differences in adherence to glaucoma medication between groups	From study baseline through the 3 months of the intervention
Primary	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	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