Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment: A Mixed Method Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change to the Glaucoma Treatment Compliance Assessment Tool (GTCAT-28)
研究概览
简要总结
This study evaluates the addition of an educational intervention program in order to improve medication adherence in glaucoma patients. Half of the participants will receive the educational program while the other half will receive normal care and a leaflet about glaucoma.
详细描述
Introduction. As the world population ages, glaucoma is becoming an increasingly significant cause of blindness. Statistics gathered by WHO in 2010, show that glaucoma is the leading cause of irreversible blindness, worldwide. A key component in the management of glaucoma, is the use of prescribed medications· but the effectiveness of medications depends on patient's adherence to treatment. However, there is evidence of poor adherence to prescribed medication in chronic diseases and a causative factor for that is the limited education and the low health literacy. This study aims to investigate the reasons of non-adherence to the medication plan among patients with glaucoma and secondly, according the findings, to develop and implement a comprehensive educational program.
Methods and analysis. This is a mixed method study which include 3 stages: a descriptive study (stage 1), focus group discussion (stage 2) and a randomised control trial (stage 3). Sample: Patients with glaucoma, using at least one kind of drops, will be recruited from the two ophthalmology clinics in Cyprus. Selected measures include: Glaucoma Treatment Compliance Assessment Tool (GTCAT), European Health Literacy Survey Questionnaire (HLS-EU-Q6) and the Glaucoma Medication Self-Efficacy Questionnaire (GMSEQ). The data will be analysed by SPSS program with descriptive and inferential statistics. Content analysis will be used for the data from the focus groups.
Ethics and dissemination. Permission to conduct the study received from the Cyprus National Bioethics Committee (ΕΕΒΚ ΕΠ 2019.01.220) and the board of management of the two ophthalmology clinics. All participants will be informed fully on the purpose and methods of the study. Consent forms will be signed and at any time participants will have the right to withdraw. Confidentiality of the participants will be respected as also the protection of data. Dissemination strategy includes presentations in international and national scientific conferences and publications in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •Patients older than 18 years of age
- •Ability to read and understand Greek
- •Able to give informed consent
- •Diagnosis of glaucoma or ocular hypertension, requiring treatment with hypotensive eye drops (at least one time per day).
- •Patients who scored less than 80% adherent on GTCAT
排除标准
- 未提供
结局指标
主要结局
Change to the Glaucoma Treatment Compliance Assessment Tool (GTCAT-28)
时间窗: T0: before intervention (4-12 months before), T1: immediately after the intervention (same day), T2: One month after the intervention, T3: Three months after the intervention
Easy and quick questionnaire specially designed for patients with glaucoma. It contains 27 statements with 5-interval Likert-type scale response (eg, 1- disagree a lot, 5-agree a lot) and 1 open ended question for assessing the knowledge, the Health Belief Model components (Barriers, Benefits, Cues to Action, Self-efficacy, Severity, Susceptibility), the patient-physician relationship, and their physical and mental health. The correct answers range from 0 to 27, with the highest score indicating more adherence to the treatment. The purpose is to assess the change between several time points (e.g. before the intervention, after the intervention-same day, one month after the intervention and three months after the intervention). The reason is, firstly, to assess if there is a change between T0 and T1 and secondly to assess if the effect of the intervention (as indicated by the change in the GTCAT) remain for a longer period of time.
次要结局
- Change to the Glaucoma Medication Self-Efficacy Questionnaire (GMSEQ-16)(T0: before the intervention (4-12 months before), T1: immediately after the intervention (same day), T2: One month after the intervention, T3: Three months after the intervention)
- European Health Literacy Survey Questionnaire (HLS-EU-Q6)(T0: before the intervention (4-12 months before))
研究者
Maria Achilleos
Principal investigator
Cyprus University of Technology