Eye Patient Adherence and Compliance Study

ConditionsGlaucoma Medication Adherence Glaucoma Patients

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSt. Joseph's Healthcare Hamilton

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years and older

Clinical diagnosis of glaucoma or ocular hypertension confirmed by an ophthalmologist

Currently prescribed at least one topical intraocular pressure (IOP)-lowering medication

Self-reported or documented missed ≥20% of prescribed eye drops

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Eye Droppers
Behavioral
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.
Eye Educate
Behavioral
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.
Eye Coordinate
Behavioral
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.
Eye Help
Behavioral
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.
Eye Refer
Behavioral
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.

Treatment groups

189 Participants

are divided into 5 treatment groups

Group A: Eye DroppersExperimental treatment 1 intervention

Group B: Eye EducateExperimental treatment 1 intervention

Group C: Eye CoordinateExperimental treatment 1 intervention

Group D: Eye HelpExperimental treatment 1 intervention

Group E: Eye ReferExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline and 12 months

Secondary outcomes

Follow-up compliance - Change in Follow-up Appointment Completion Rate

Follow-up compliance will be assessed using clinic attendance records. For each participant, scheduled glaucoma follow-up appointments during the study period will be classified as completed, missed/no-show, or cancelled. The appointment completion rate will be calculated as the number of completed scheduled follow-up appointments divided by the total number of scheduled follow-up appointments, expressed as a percentage. Higher percentages indicate better follow-up compliance.

Time frame

baseline, 1, 3, 6, 9, and 12 months

Vision-related quality of life - Change in Glaucoma Quality of Life-15 (GQL-15) Score

Vision-related quality of life will be assessed using the 15-item Glaucoma Quality of Life-15 (GQL-15) questionnaire. Each activity is rated according to the degree of difficulty experienced because of vision, from 1 (no difficulty) to 5 (severe difficulty); a response of 0 indicates that the activity is not performed for reasons unrelated to vision. When all 15 items are scorable, the total GQL-15 score ranges from 15 to 75. Higher scores indicate greater vision-related difficulty and poorer quality of life. Change from baseline will be assessed at 6 and 12 months; a decrease in score indicates improvement in vision-related quality of life. Higher scores indicate greater participant satisfaction with the intervention, including perceived usefulness, clarity of education, ease of participation, communication with the EYE-PAC team, and overall experience.

Time frame

6 months and 12 months.

Activity limitation - Change in Glaucoma Activity Limitation-9 (GAL-9) Score

Vision-related activity limitation will be assessed using the 9-item Glaucoma Activity Limitation-9 (GAL-9) questionnaire. Each item assesses difficulty performing a vision-dependent activity using a 5-category response scale ranging from 1 (no difficulty) to 5 (severe difficulty). If the raw item scores are summed, the total score ranges from 9 to 45, with higher scores indicating greater vision-related activity limitation. Change from baseline will be assessed at 6 and 12 months; a decrease in score indicates improvement in vision-related functioning.

Time frame

Time Frame: Baseline, 6 months and 12 months.

Other outcomes

Primary Adherence Barrier Category at Baseline - Primary Adherence Barrier Category Identified at Baseline

Patient-reported barriers to glaucoma treatment adherence and follow-up will be assessed using the High-Risk Questionnaire (HRQ) together with relevant GTCAT responses. Each participant will be assigned one highest-priority adherence barrier based on the baseline assessment. Barrier categories include patient-related, provider-related, medication regimen-related, and social/environmental factors. Results will be summarised as the number and percentage of participants classified within each primary barrier category.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Joseph's Healthcare Hamilton

Lead sponsor

Source ClinicalTrials.gov

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