Eye Patient Adherence and Compliance Study

N/ANot Yet RecruitingNCT07793474

St. Joseph's Healthcare Hamilton189 enrolled

Overview

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.

This study will enroll adult patients with glaucoma who are identified as being at high risk for poor medication adherence or inconsistent follow-up with clinic visits. Following informed consent, participants will undergo baseline assessments that include a structured questionnaire to identify barriers to adherence and compliance, as well as standardized tools to measure medication adherence and vision-related quality of life. Clinical information relevant to glaucoma management will be obtained as part of routine care. Each participant will then be assigned to a single, tailored intervention based on their most significant self-identified barrier to care. These interventions reflect established components of standard glaucoma care and may include targeted education about the disease and its treatment, reminder systems to support medication use, training or assistance with proper eye drop administration, coordination of transportation for clinic visits, or enhanced care navigation and referral support. The goal is to provide individualized, practical support that directly addresses the participant's primary challenge. All participants will continue to receive their usual ophthalmic care throughout the study period, and no experimental therapies will be introduced. Follow-up assessments will be conducted at multiple time points over approximately 12 months to evaluate changes in medication adherence, clinic attendance, and quality of life. These assessments will use the same validated tools administered at baseline to allow for comparison over time. Data collected during the study will be analyzed to assess within-participant changes in outcomes following the intervention. The study will also explore patterns between types of barriers and improvements in adherence and related outcomes. The findings are intended to inform future approaches to improving glaucoma care by identifying practical, patient-centred strategies that can be integrated into routine clinical practice.

Study Type

Interventions

Eye DroppersBEHAVIORAL

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 EducateBEHAVIORAL

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 CoordinateBEHAVIORAL

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 HelpBEHAVIORAL

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 ReferBEHAVIORAL

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Participants will be eligible for inclusion if they meet all of the following criteria: * 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 * Identified as high risk for non-adherence and/or poor follow-up, defined by one or more of the following: * Self-reported or documented missed ≥20% of prescribed eye drops * Missed two or more glaucoma clinic appointments * Evidence of structural or functional glaucoma progression (e.g., OCT or visual field deterioration) * Willing to participate in study interventions and follow-up assessments Able to communicate in the study language. Exclusion Criteria 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)

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.