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Real-time Glaucoma Medication Adherence

Primary Purpose

Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication reminder
Medication monitoring only
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Glaucoma focused on measuring Adherence, Mobile health, Real-time data

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Barney's Pharmacy
  • Barney's Pharmacy
  • Barney's Pharmacy
  • Barney's Pharmacy
  • Hutton Pharmacy
  • Creative Care Pharmacy
  • Mustang Drug
  • University of Tennessee College of Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monitoring only

Monitoring and reminder

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adherence
Changes and differences in adherence to glaucoma medication between groups
Adherence follow-up
Changes and differences in adherence to glaucoma medication between groups after the intervention

Secondary Outcome Measures

Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale
Differences in self-reported medication-related self-efficacy between groups

Full Information

First Posted
May 9, 2017
Last Updated
November 5, 2018
Sponsor
University of Tennessee
Collaborators
Kali Care, Barney's Pharmacy, Creative Care Pharmacy, Hutton Pharmacy, Mustang Drug
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1. Study Identification

Unique Protocol Identification Number
NCT03194828
Brief Title
Real-time Glaucoma Medication Adherence
Official Title
Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of sufficient recruitment
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
Kali Care, Barney's Pharmacy, Creative Care Pharmacy, Hutton Pharmacy, Mustang Drug

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Adherence, Mobile health, Real-time data

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitoring only
Arm Type
Active Comparator
Arm Description
Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months
Arm Title
Monitoring and reminder
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Medication reminder
Intervention Description
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
Intervention Name(s)
Medication monitoring only
Intervention Description
Patients will use an electronic medication monitoring device to record their actual medication use
Primary Outcome Measure Information:
Title
Adherence
Description
Changes and differences in adherence to glaucoma medication between groups
Time Frame
From study baseline through the 3 months of the intervention
Title
Adherence follow-up
Description
Changes and differences in adherence to glaucoma medication between groups after the intervention
Time Frame
From study endpoint through the subsequent 3 months
Secondary Outcome Measure Information:
Title
Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale
Description
Differences in self-reported medication-related self-efficacy between groups
Time Frame
Change from baseline over the 3-month intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Gatwood, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barney's Pharmacy
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30906
Country
United States
Facility Name
Barney's Pharmacy
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30907
Country
United States
Facility Name
Barney's Pharmacy
City
Grovetown
State/Province
Georgia
ZIP/Postal Code
30813
Country
United States
Facility Name
Barney's Pharmacy
City
Louisville
State/Province
Georgia
ZIP/Postal Code
30434
Country
United States
Facility Name
Hutton Pharmacy
City
Blackwell
State/Province
Oklahoma
ZIP/Postal Code
74631
Country
United States
Facility Name
Creative Care Pharmacy
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Mustang Drug
City
Mustang
State/Province
Oklahoma
ZIP/Postal Code
73064
Country
United States
Facility Name
University of Tennessee College of Pharmacy
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD

Learn more about this trial

Real-time Glaucoma Medication Adherence

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