Eye Patient Adherence and Compliance Study-Intervention Program (EYE-PACIP): Improving Glaucoma Adherence and Compliance in High-risk Patients With a Multi-interventional Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Change in Glaucoma Treatment Compliance Assessment Tool (GTCAT) Score from Baseline to 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Not applicable. This is an open-label study with no masking; participants, care providers, and study personnel are all aware of the assigned intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Eye Refer
Care coordination and referral support
干预措施: Eye Refer (Behavioral)
Eye Droppers
Training in proper eyedrop administration
干预措施: Eye Droppers (Behavioral)
Eye Educate
Glaucoma education sessions
干预措施: Eye Educate (Behavioral)
Eye Coordinate
Reminder systems for medication use
干预措施: Eye Coordinate (Behavioral)
Eye Help
Transportation support
干预措施: Eye Help (Behavioral)
结局指标
主要结局
Change in Glaucoma Treatment Compliance Assessment Tool (GTCAT) Score from Baseline to 12 Months
时间窗: Baseline and 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.
次要结局
- 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.)
研究者
Enitan Sogbesan
Assistant Professor of Ophthalmology
St. Joseph's Healthcare Hamilton