NCT03194828

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
Last Updated

November 7, 2018

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

May 9, 2017

Last Update Submit

November 5, 2018

Conditions

Glaucoma

Keywords

AdherenceMobile healthReal-time data

Outcome Measures

Primary Outcomes (2)

  • Adherence

    Changes and differences in adherence to glaucoma medication between groups

    From study baseline through the 3 months of the intervention

  • 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 Outcomes (1)

  • Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale

    Change from baseline over the 3-month intervention

Study Arms (2)

Monitoring only

ACTIVE COMPARATOR

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

Monitoring and reminder

EXPERIMENTAL

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

Interventions

Medication reminderBEHAVIORAL

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

Monitoring and reminder
Medication monitoring onlyBEHAVIORAL

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

Monitoring only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Barney's Pharmacy

Augusta, Georgia, 30906, United States

Location

Barney's Pharmacy

Augusta, Georgia, 30907, United States

Location

Barney's Pharmacy

Grovetown, Georgia, 30813, United States

Location

Barney's Pharmacy

Louisville, Georgia, 30434, United States

Location

Hutton Pharmacy

Blackwell, Oklahoma, 74631, United States

Location

Creative Care Pharmacy

Edmond, Oklahoma, 73013, United States

Location

Mustang Drug

Mustang, Oklahoma, 73064, United States

Location

University of Tennessee College of Pharmacy

Nashville, Tennessee, 37210, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Justin Gatwood, PhD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

June 21, 2017

Study Start

May 8, 2017

Primary Completion

July 15, 2018

Study Completion

July 15, 2018

Last Updated

November 7, 2018

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

No IPD

Locations

US(8)