Clinical trial NCT04245163: Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment
Official title: Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment: A Mixed Method Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: medication adherence
education*
intervention
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who will be randomized in control group will receive normal care (the care that each clinic provides to the patients) and will be given an educational material (without telling them that they are in the control group). They will receive, however, the education class later (at the end of the study). Participants in the intervention group will be invited for the training program
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Change to the Glaucoma Treatment Compliance Assessment Tool (GTCAT-28)
timeFrame: 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
Secondary outcomes:
measure: European Health Literacy Survey Questionnaire (HLS-EU-Q6)
timeFrame: T0: before the intervention (4-12 months before)
measure: Change to the Glaucoma Medication Self-Efficacy Questionnaire (GMSEQ-16)
timeFrame: 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
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Pantheon Eye Center
Study officials:
References: