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Real-time Glaucoma Medication Adherence

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ClinicalTrials.gov Identifier: NCT03194828
Recruitment Status : Terminated (Lack of sufficient recruitment)
First Posted : June 21, 2017
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
Kali Care
Barney's Pharmacy
Creative Care Pharmacy
Hutton Pharmacy
Mustang Drug
Information provided by (Responsible Party):
University of Tennessee

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.

Condition or disease Intervention/treatment Phase
Glaucoma Behavioral: Medication reminder Behavioral: Medication monitoring only Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: 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
Behavioral: Medication monitoring only
Patients will use an electronic medication monitoring device to record their actual medication use

Experimental: 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
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




Primary Outcome Measures :
  1. Adherence [ Time Frame: From study baseline through the 3 months of the intervention ]
    Changes and differences in adherence to glaucoma medication between groups

  2. 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


Secondary Outcome Measures :
  1. Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale [ Time Frame: Change from baseline over the 3-month intervention ]
    Differences in self-reported medication-related self-efficacy between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194828


Locations
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United States, Georgia
Barney's Pharmacy
Augusta, Georgia, United States, 30906
Barney's Pharmacy
Augusta, Georgia, United States, 30907
Barney's Pharmacy
Grovetown, Georgia, United States, 30813
Barney's Pharmacy
Louisville, Georgia, United States, 30434
United States, Oklahoma
Hutton Pharmacy
Blackwell, Oklahoma, United States, 74631
Creative Care Pharmacy
Edmond, Oklahoma, United States, 73013
Mustang Drug
Mustang, Oklahoma, United States, 73064
United States, Tennessee
University of Tennessee College of Pharmacy
Nashville, Tennessee, United States, 37210
Sponsors and Collaborators
University of Tennessee
Kali Care
Barney's Pharmacy
Creative Care Pharmacy
Hutton Pharmacy
Mustang Drug
Investigators
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Principal Investigator: Justin Gatwood, PhD University of Tennessee Health Science Center

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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT03194828     History of Changes
Other Study ID Numbers: 17-05074-XP
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Tennessee:
Adherence
Mobile health
Real-time data
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases