Real-time Glaucoma Medication Adherence

NCT ID: NCT03194828

Last Updated: 2018-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-08

Study Completion Date

2018-07-15

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Medication monitoring only

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Medication reminder

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Medication monitoring only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kali Care

UNKNOWN

Sponsor Role collaborator

Barney's Pharmacy

UNKNOWN

Sponsor Role collaborator

Creative Care Pharmacy

UNKNOWN

Sponsor Role collaborator

Hutton Pharmacy

UNKNOWN

Sponsor Role collaborator

Mustang Drug

UNKNOWN

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Gatwood, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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Barney's Pharmacy

Augusta, Georgia, United States

Site Status

Barney's Pharmacy

Augusta, Georgia, United States

Site Status

Barney's Pharmacy

Grovetown, Georgia, United States

Site Status

Barney's Pharmacy

Louisville, Georgia, United States

Site Status

Hutton Pharmacy

Blackwell, Oklahoma, United States

Site Status

Creative Care Pharmacy

Edmond, Oklahoma, United States

Site Status

Mustang Drug

Mustang, Oklahoma, United States

Site Status

University of Tennessee College of Pharmacy

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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17-05074-XP

Identifier Type: -

Identifier Source: org_study_id

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