Clinical trial NCT06706089: Nurse-led Educational Intervention on Patients With Glaucoma With Low Health Literacy
Official title: Nurse-led Educational Intervention on Patients With Glaucoma With Low Health Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Health Literacy
Patient Activation
Keywords: Health literacy
glaucoma
patient activation
Nurse-led training intervention
Lead sponsor: Hellenic Mediterranean University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Health literacy Survey Questionnaire (HLS-EU-16)
timeFrame: From enrollment to the end of the intervention at 6 months
measure: Patient Activation Measure - 13 (PAM-13)
timeFrame: From enrollment to the end of the intervention at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Hellenic Mediterranean University
state: Crete
Study officials:
References: