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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Educational program
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma focused on measuring medication adherence, education*, intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pantheon Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Participants in the intervention group will be invited for the training program.

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).

Outcomes

Primary Outcome Measures

Change to the Glaucoma Treatment Compliance Assessment Tool (GTCAT-28)
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.

Secondary Outcome Measures

European Health Literacy Survey Questionnaire (HLS-EU-Q6)
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.
Change to the Glaucoma Medication Self-Efficacy Questionnaire (GMSEQ-16)
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.

Full Information

First Posted
January 23, 2020
Last Updated
March 8, 2021
Sponsor
Cyprus University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04245163
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2021 (Anticipated)
Primary Completion Date
July 10, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
medication adherence, education*, intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants in the intervention group will be invited for the training program.
Arm Title
Control Group
Arm Type
No Intervention
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Educational program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change to the Glaucoma Treatment Compliance Assessment Tool (GTCAT-28)
Description
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.
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
Secondary Outcome Measure Information:
Title
European Health Literacy Survey Questionnaire (HLS-EU-Q6)
Description
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.
Time Frame
T0: before the intervention (4-12 months before)
Title
Change to the Glaucoma Medication Self-Efficacy Questionnaire (GMSEQ-16)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Achilleos, PhDcandidate
Phone
+357 95119123
Email
maria_ach_@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Evridiki Papastavrou, Professor
Phone
+357 25 002021
Email
e.papastavrou@cut.ac.cy
Facility Information:
Facility Name
Pantheon Eye Center
City
Limassol
ZIP/Postal Code
3076
Country
Cyprus
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Achilleos, PhD Cand.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.eugs.org/eng/default.asp
Description
European Glaucoma Society

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

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