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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

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE June 21, 2017
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE May 8, 2017
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • Adherence [ Time Frame: From study baseline through the 3 months of the intervention ]
    Changes and differences in adherence to glaucoma medication between groups
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03194828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Real-time Glaucoma Medication Adherence
Official Title  ICMJE Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • 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
  • Behavioral: Medication monitoring only
    Patients will use an electronic medication monitoring device to record their actual medication use
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Medication monitoring only
  • 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
    Intervention: Behavioral: Medication reminder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
5
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
80
Actual Study Completion Date  ICMJE July 15, 2018
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03194828
Other Study ID Numbers  ICMJE 17-05074-XP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD
Responsible Party University of Tennessee
Study Sponsor  ICMJE University of Tennessee
Collaborators  ICMJE
  • Kali Care
  • Barney's Pharmacy
  • Creative Care Pharmacy
  • Hutton Pharmacy
  • Mustang Drug
Investigators  ICMJE
Principal Investigator: Justin Gatwood, PhD University of Tennessee Health Science Center
PRS Account University of Tennessee
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP