Nurse-led Educational Intervention on Patients With Glaucoma With Low Health Literacy

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 Overview

• Status: Completed
• Conditions: Glaucoma; Health Literacy; Patient Activation
• Intervention / Treatment: Other: Nurse-led educational intervention

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Crete
    • Heraklion, Crete, Greece, 71410
      • Hellenic Mediterranean University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with incomplete health records
• Patients who provided incomplete information
• Patients who wished to stop participating were excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention: Control Group: Group A (N=156); This group did not receive this study's intervention, and were only used for comparisons with the experimental group.
Experimental: Experimental: Group B: Intervention Group (N=156); This group received the described intervention of this study.	Other: Nurse-led educational intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to the end of the intervention at 6 months

Collaborators and Investigators

• Sponsor: Hellenic Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: patient activation; glaucoma; Health literacy; Nurse-led training intervention
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 103/08.04.2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No