Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment

March 8, 2021 updated by: Maria Achilleos, Cyprus University of Technology

Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment: A Mixed Method Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Cyprus
      • Limassol, Cyprus, 3076
        • Pantheon Eye Center
        • Contact:
          • Maria Achilleos, PhD Cand.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants in the intervention group will be invited for the training program.
Behavioral: Educational program
The intervention program will include 3 phases. At phase 1 a presentation on Microsoft PowerPoint in order to increase the general knowledge about glaucoma. At phase 2 a video and a one on one teaching to develop skills of administering the eye drops in a correct and systematic way. At phase 3, a discussion in order to identify cues to action that can easily be adopted by the patient in his/her daily routine, (such as, how to remember to put in drops) will take place.
No Intervention: Control Group
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change to the Glaucoma Treatment Compliance Assessment Tool (GTCAT-28)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Health Literacy Survey Questionnaire (HLS-EU-Q6)
Time Frame: T0: before the intervention (4-12 months before)
The HLS-EU-Q6, includes 6 statements with 5-interval Likert-type scale response (eg, 1- disagree a lot, 5-agree a lot). We will use the HLS-EU-Q6 to assess the level of Health Literacy among the participants.
T0: before the intervention (4-12 months before)
Change to the Glaucoma Medication Self-Efficacy Questionnaire (GMSEQ-16)
Time Frame: 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
The GMSEQ consists of 10 questions assessing Self-Efficacy in Glaucoma medication in general and 6 questions assessing Self-Efficacy in the eye drop technique. The response categories are: 'not at all confident', 'somewhat confident', 'very confident' and 'does not apply'. 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 to assess firstly if there is a change (between T0 and T1) and secondly to asses if the effect of the intervention (as indicated by the change in the GMSEQ-16) remain for a longer period of time.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 10, 2021

Primary Completion (Anticipated)

July 10, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 25, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUT15012018MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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