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

NCT ID: NCT06706089

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2024-10-15

Brief 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. 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.

Conditions

Glaucoma; Health Literacy; Patient Activation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental: Group B: Intervention Group (N=156)

This group received the described intervention of this study.

Group Type: EXPERIMENTAL

Nurse-led educational intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Giakoumidakis

Associate Professor, Department of Nursing, School of Health Sciences, Hellenic Mediterranean University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hellenic Mediterranean University

Heraklion, Crete, Greece

Countries

Greece

Other Identifiers

103/08.04.2023

Identifier Type: -

Identifier Source: org_study_id