GlaucomaNCT06706089
Nurse-led Educational Intervention on Patients With Glaucoma With Low Health Literacy
A study testing Nurse-led educational intervention in people with Glaucoma and Health Literacy, run by Hellenic Mediterranean University at 1 site in Greece.
Trial summary
Introduction: Chronic diseases are a major cause of ill health, disability and death worldwide and are potentially preventable and treatable. Glaucoma is among the main causes of morbidity and blindness; its early detection can reduce the risk of poor patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glaucoma, Health Literacy, Patient Activation
- What is being tested?
- Nurse-led educational intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteGreece
- Study dates
- 20 Nov 2023to 15 Oct 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Informed written consent to participate in the study
- Adequate knowledge of the Greek language (writing and reading)
- Diagnosis of the condition for at least six months
Who cannot join
- Patients with incomplete health records
- Patients who provided incomplete information
- Patients who wished to stop participating were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Chronic diseases are a major cause of ill health, disability and death worldwide and are potentially preventable and treatable. Glaucoma is among the main causes of morbidity and blindness; its early detection can reduce the risk of poor patient outcomes. The existence of health illiteracy among these patients and the absence of self-management of these diseases are a barrier to their effective management worldwide.
Aim: The investigation of effect of a nurse-led patient education on both the incidence of negative outcomes and the activation levels of glaucoma patients with low health literacy status. Secondary objectives of the present study are the assessment of patient activation and health literacy prior to (baseline) and after (follow-up period)patient education at predefined times, as well as the association of patient socio-demographic and clinical parameters with the patient activation and health literacy levels.
Read more
Methodology: A quasi experimental study will be conducted with follow-up in a population of patients with diagnosed glaucoma, who will attend the outpatient ophthalmological clinic of the Heraklion University General Hospital. The research tools that will be used for the assessment of health literacy will be the Greek version of the European Health Literacy Survey Questionnaire 16 (HLS-EU-16) and for the assessment of the patients' activation level the Patient Activation Measure - 13 (PAM-13) questionnaire will be used, which will be translated . The data will be analyzed using the Statistical Package for Social Sciences (SPSS) (IBM Statistics) software program, version 24.0, and ethical and moral rules will be followed.
Expected results: The proposed study is expected to underline both the level of health literacy of glaucoma patients in Greece and the importance of self-management of chronic diseases carried by patients. Additionally, the present study is expected to highlight the significance of the nurse-led education process of patients with low health literacy status on reducing the poor patient outcomes incidence and the improvement of their activation levels, leading to the optimal self-management and self-care.
- Conditions
- Glaucoma, Health Literacy, Patient Activation
- Being tested
- Nurse-led educational intervention
- Keywords
- Health literacy, glaucoma, patient activation, Nurse-led training intervention
- Medical subject headings
- Glaucoma, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led educational interventionOther
This nurse-led educational intervention included: a) an oral training session regarding glaucoma by the P.I. lasting 15 minutes, b) provision of printed informational material (leaflet) and c) provision of appropriately selected free informational videos from the World Glaucoma Association on the "YouTube" -online platform. All of the above mentioned educational methods focused on the disease, its treatment and its long-term management. The oral training session took place in an appropriate, quiet and clean area, respecting the patient's privacy. During this process, study participants had the opportunity and time to ask questions and ask for clarifications or additional information.
| Study group | Role | What they receive |
|---|---|---|
| No intervention: Control Group: Group A (N=156) | No intervention | This group did not receive this study's intervention, and were only used for comparisons with the experimental group. |
| Experimental: Group B: Intervention Group (N=156) | Experimental | This group received the described intervention of this study. Receives: Other: Nurse-led educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy Survey Questionnaire (HLS-EU-16)
The assessment of health literacy using the Greek version of the European Health Literacy Survey Questionnaire (HLS-EU-16) is an important method for understanding participants' knowledge and skills in managing their health.
In the HLS-EU-16, each question is scored from 1 to 4 based on how easily participants understand and apply health-related information:
- = Very difficult
- = Difficult
- = Easy
- = Very easy
Minimum score: The lowest score is 16 (1 x 16 questions), indicating very low health literacy.
Maximum score: The highest score is 64 (4 x 16 questions), indicating high health literacy.
Health Literacy Levels: The total score is converted to a percentage and classified as follows:
- Sufficient health literacy: Easily understands and applies health information.
- Problematic health literacy: Has difficulty understanding or applying health information.
- Inadequate health literacy: Faces major challenges using basic health information, impacting health outcomes.
Measured: From enrollment to the end of the intervention at 6 months
Patient Activation Measure - 13 (PAM-13)
The Patient Activation Measure - 13 (PAM-13) is widely used to assess patient activation, meaning patients' willingness and ability to manage their health and make informed decisions to improve their quality of life. The PAM-13 includes 13 questions rated on a 4-point Likert scale from [1] "strongly disagree" to [4] "strongly agree," with a "not applicable" option. To calculate the PAM score, responses are summed, divided by the number of valid responses (excluding "not applicable"), and multiplied by 13. This raw score is then converted to a final score from 1 to 100 using calibration tables. Based on this score, patients are classified as follows:
- Level 1 (≤ 47.0): Patients lack belief in activation.
- Level 2 (47.1-55.1): Patients understand but find action difficult .• Level 3 (55.2-67.0): Patients actively manage their health.
- Level 4 (≥ 67.1): Patients continue positive behaviors.
Measured: From enrollment to the end of the intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start20 Nov 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
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
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Giakoumidakis, Hellenic Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706089
- Sponsor's protocol ID
- 103/08.04.2023
- Status last verified
- Nov 2024
- First submitted
- 18 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Educational Intervention on Patients With Glaucoma With Low Health Literacy
- ClinicalTrials.gov ID
- NCT06706089
- Acronym / sponsor ID
- 103/08.04.2023
- Conditions
- Glaucoma, Health Literacy, Patient Activation
- Keywords
- Health literacy, glaucoma, patient activation, Nurse-led training intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Hellenic Mediterranean UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 26 Nov 2024 (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.
Introduction: Chronic diseases are a major cause of ill health, disability and death worldwide and are potentially preventable and treatable. Glaucoma is among the main causes of morbidity and blindness; its early detection can reduce the risk of poor patient outcomes. The existence of health illiteracy among these patients and the absence of self-management of these diseases are a barrier to their effective management worldwide.
Aim: The investigation of effect of a nurse-led patient education on both the incidence of negative outcomes and the activation levels of glaucoma patients with low health literacy status. Secondary objectives of the present study are the assessment of patient activation and health literacy prior to (baseline) and after (follow-up period)patient education at predefined times, as well as the association of patient socio-demographic and clinical parameters with the patient activation and health literacy levels.
Methodology: A quasi experimental study will be conducted with follow-up in a population of patients with diagnosed glaucoma, who will attend the outpatient ophthalmological clinic of the Heraklion University General Hospital. The research tools that will be used for the assessment of health literacy will be the Greek version of the European Health Literacy Survey Questionnaire 16 (HLS-EU-16) and for the assessment of the patients' activation level the Patient Activation Measure - 13 (PAM-13) questionnaire will be used, which will be translated . The data will be analyzed using the Statistical Package for Social Sciences (SPSS) (IBM Statistics) software program, version 24.0, and ethical and moral rules will be followed.
Expected results: The proposed study is expected to underline both the level of health literacy of glaucoma patients in Greece and the importance of self-management of chronic diseases carried by patients. Additionally, the present study is expected to highlight the significance of the nurse-led education process of patients with low health literacy status on reducing the poor patient outcomes incidence and the improvement of their activation levels, leading to the optimal self-management and self-care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention: Control Group: Group A (N=156) | No intervention | –This group did not receive this study's intervention, and were only used for comparisons with the experimental group. |
| Experimental: Group B: Intervention Group (N=156) | Experimental | Other: Nurse-led educational interventionThis group received the described intervention of this study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Informed written consent to participate in the study
- Adequate knowledge of the Greek language (writing and reading)
- Diagnosis of the condition for at least six months
Key exclusion criteria (3 listed)
- Patients with incomplete health records
- Patients who provided incomplete information
- Patients who wished to stop participating were excluded
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 |
|---|---|---|
| Nurse-led educational interventionThis nurse-led educational intervention included: a) an oral training session regarding glaucoma by the P.I. lasting 15 minutes, b) provision of printed informational material (leaflet) and c) provision of appropriately selected free informational videos from the World Glaucoma Association on the "YouTube" -online platform. All of the above mentioned educational methods focused on the disease, its treatment and its long-term management. The oral training session took place in an appropriate, quiet and clean area, respecting the patient's privacy. During this process, study participants had the opportunity and time to ask questions and ask for clarifications or additional information. | Other | Experimental: Group B: Intervention Group (N=156) |
Primary outcome
Health literacy Survey Questionnaire (HLS-EU-16)
Time frame: From enrollment to the end of the intervention at 6 months
The assessment of health literacy using the Greek version of the European Health Literacy Survey Questionnaire (HLS-EU-16) is an important method for understanding participants' knowledge and skills in managing their health. In the HLS-EU-16, each question is scored from 1 to 4 based on how easily participants understand and apply health-related information: 1. = Very difficult 2. = Difficult 3. = Easy 4. = Very easy Minimum score: The lowest score is 16 (1 x 16 questions), indicating very low health literacy. Maximum score: The highest score is 64 (4 x 16 questions), indicating high health literacy. Health Literacy Levels: The total score is converted to a percentage and classified as follows: * Sufficient health literacy: Easily understands and applies health information. * Problematic health literacy: Has difficulty understanding or applying health information. * Inadequate health literacy: Faces major challenges using basic health information, impacting health outcomes.
Patient Activation Measure - 13 (PAM-13)
Time frame: From enrollment to the end of the intervention at 6 months
The Patient Activation Measure - 13 (PAM-13) is widely used to assess patient activation, meaning patients' willingness and ability to manage their health and make informed decisions to improve their quality of life. The PAM-13 includes 13 questions rated on a 4-point Likert scale from [1] "strongly disagree" to [4] "strongly agree," with a "not applicable" option. To calculate the PAM score, responses are summed, divided by the number of valid responses (excluding "not applicable"), and multiplied by 13. This raw score is then converted to a final score from 1 to 100 using calibration tables. Based on this score, patients are classified as follows: * Level 1 (≤ 47.0): Patients lack belief in activation. * Level 2 (47.1-55.1): Patients understand but find action difficult .• Level 3 (55.2-67.0): Patients actively manage their health. * Level 4 (≥ 67.1): Patients continue positive behaviors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led educational intervention in people with Glaucoma and Health Literacy, run by Hellenic Mediterranean University at 1 site in Greece.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Nov 2024. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy Survey Questionnaire (HLS-EU-16) (time frame: From enrollment to the end of the intervention at 6 months). The study lists 2 primary outcomes in all. 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 26 Nov 2024.