GlaucomaNCT04245163
Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment
A study testing Educational program in people with Glaucoma, run by Cyprus University of Technology at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 10 Jun 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Educational program
- Keywords
- medication adherence, education*, intervention
- Medical subject headings
- Glaucoma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will be invited for the training program. Receives: Behavioral: Educational program |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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.
Measured: T0: before the intervention (4-12 months before)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start10 Jun 2021 (estimated)
- Primary completion10 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Achilleos, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245163
- Sponsor's protocol ID
- CUT15012018MA
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT04245163
- Acronym / sponsor ID
- CUT15012018MA
- Conditions
- Glaucoma
- Keywords
- medication adherence, education*, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Study start
- 10 Jun 2021 (estimated)
- Primary completion
- 10 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Educational programParticipants in the intervention group will be invited for the training program. |
| Control Group | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational programThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
2 secondary outcomes
European Health Literacy Survey Questionnaire (HLS-EU-Q6)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in people with Glaucoma, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Achilleos, PhDcandidate (+357 95119123, maria_ach_@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.