Eye Patient Adherence and Compliance Study
EYE-PACIP
1 other identifier
interventional
189
1 country
1
Brief Summary
This study looks at ways to help people with glaucoma take their eye drops regularly and attend their clinic appointments. Each participant will be asked about the main challenges they face, such as forgetfulness, difficulty using drops, lack of transportation, or limited understanding of their condition. Based on their biggest challenge, participants will receive one type of support that is already part of usual care, such as education, reminders, help with applying drops, or assistance getting to appointments. The investigators will follow participants over time to see if this support improves how well they follow their treatment and their quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2026
CompletedFirst Posted
Study publicly available on registry
August 28, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
March 31, 2028
August 28, 2026
August 1, 2026
1.3 years
May 4, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Glaucoma Treatment Compliance Assessment Tool (GTCAT) Score from Baseline to 12 Months
Medication adherence will be assessed using the 27-statement Glaucoma Treatment Compliance Assessment Tool-Short Form (GTCAT-S). The GTCAT-S assesses behavioural factors associated with glaucoma medication adherence, including knowledge, susceptibility, cues to action, self-efficacy, and treatment barriers. A derived adherence score ranges from 0 to 27, with higher scores indicating greater adherence to glaucoma treatment. The primary outcome will be the within-participant change in GTCAT-S score from baseline to 12 months, calculated as the 12-month score minus the baseline score. A positive change indicates improvement in medication adherence.
Baseline and 12 months
Secondary Outcomes (3)
Follow-up compliance - Change in Follow-up Appointment Completion Rate
baseline, 1, 3, 6, 9, and 12 months
Vision-related quality of life - Change in Glaucoma Quality of Life-15 (GQL-15) Score
6 months and 12 months.
Activity limitation - Change in Glaucoma Activity Limitation-9 (GAL-9) Score
Time Frame: Baseline, 6 months and 12 months.
Other Outcomes (1)
Primary Adherence Barrier Category at Baseline - Primary Adherence Barrier Category Identified at Baseline
Baseline
Study Arms (5)
Eye Droppers
EXPERIMENTALTraining in proper eyedrop administration
Eye Educate
EXPERIMENTALGlaucoma education sessions
Eye Coordinate
EXPERIMENTALReminder systems for medication use
Eye Help
EXPERIMENTALTransportation support
Eye Refer
EXPERIMENTALCare coordination and referral support
Interventions
Participants in this arm receive individualized training and support to improve correct and consistent instillation of glaucoma eye drops. The intervention includes in-person or virtual instruction by the Eye Patient Adherence and Compliance Study-Intervention Program (EYE-PACIP) team on proper drop technique, use of assistive devices where needed, and caregiver training when applicable. Patients with significant physical or cognitive limitations may receive additional volunteer or home-care support. In long-term care settings, coordination with facility staff ensures adherence support. Reinforcement is provided through demonstration, return-demonstration, and follow-up monitoring of technique and adherence.
Participants receive structured glaucoma education aimed at improving disease understanding, treatment awareness, and motivation for adherence. Education is delivered through one-on-one or group sessions at the clinic and includes standardized materials (pamphlets, videos, and resources from recognized ophthalmology organizations). Content covers disease chronicity, importance of lifelong treatment, risks of non-adherence, and medication side effects. Pre- and post-intervention assessments are used to evaluate knowledge improvement.
This arm provides adherence support through structured reminder systems designed to reduce forgetfulness. Interventions include mobile phone alarms, calendar reminders, and physical reminder cards to track medication use. Weekly follow-up calls are conducted during the first month, followed by scheduled check-ins at 3, 6, and 12 months. Patients also report missed doses through logs or reminder tools, which are reviewed during follow-up to reinforce adherence behaviours.
Participants receive assistance to overcome transportation-related barriers to clinic attendance. The intervention includes coordination with community transportation services (e.g., volunteer drivers, community transport programs) and linkage to available support services. For patients in long-term care or retirement homes, mobile or outreach-based support may be arranged to facilitate continuity of follow-up care. The goal is to improve clinic attendance and reduce missed appointments.
Participants receive enhanced access to ophthalmic assessment through mobile or outreach-based clinical support. A trained ophthalmic technician conducts home or facility-based assessments, including intraocular pressure measurement, optic nerve imaging, and portable visual field testing. Findings are reviewed by an ophthalmologist to guide timely management decisions. The intervention also includes strengthened referral coordination to reduce delays in specialist care and improve continuity between primary and specialist services.
Eligibility Criteria
You may not qualify if:
- Participants will be excluded if they meet any of the following criteria:
- Significant cognitive impairment, neurodegenerative disease, or severe psychiatric illness limiting participation or understanding of the intervention
- Participation in another interventional study targeting glaucoma adherence or follow-up
- Anticipated inability to complete 12-month follow-up (e.g., planned relocation or transfer of care outside the study catchment area)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Joseph's Regional Eye Clinic
Hamilton, Ontario, L8G 5E4, Canada
Related Publications (3)
Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24.
PMID: 25912144BACKGROUNDOkeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, Friedman DS. Interventions improve poor adherence with once daily glaucoma medications in electronically monitored patients. Ophthalmology. 2009 Dec;116(12):2286-93. doi: 10.1016/j.ophtha.2009.05.026. Epub 2009 Oct 7.
PMID: 19815286BACKGROUNDQuigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PMID: 16488940BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enitan A. Sogbesan, M.D.
McMaster University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Not applicable. This is an open-label study with no masking; participants, care providers, and study personnel are all aware of the assigned intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Ophthalmology
Study Record Dates
First Submitted
May 4, 2026
First Posted
August 28, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be publicly shared due to the sensitive and potentially identifiable nature of ophthalmic clinical data, including detailed visual field results, imaging data, and longitudinal clinical histories. Given the relatively small, single-centre study population and the inclusion of detailed demographic and clinical variables, there is a potential risk of participant re-identification even after de-identification. However, aggregated and de-identified data may be made available upon reasonable request to the principal investigator, subject to institutional ethics approval and data-sharing agreements consistent with McMaster University and St. Joseph's Healthcare Hamilton policies.