- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07880613
Effectiveness of an Advanced Practice Nurse-Led Health Education Program (APN-HEALTH) (APN-HEALTH)
Effectiveness of an Advanced Practice Nurse-Led Health Education Program (Efectividad de un Programa de educación en Salud Desarrollado Por la Enfermera de Práctica Avanzada)
Advanced Practice Nursing (APN) has demonstrated a positive impact on improving health outcomes in various international clinical settings. In Spain, however, its integration is still limited and variable, especially in specialized fields such as neurology and surgery. Existing evidence suggests that health education led by an APN can improve key indicators such as health literacy, self-efficacy, and patient satisfaction, although further research is needed in our context.
Hypothesis: Health education provided by an APN significantly improves health literacy, self-efficacy, quality of life, and the healthcare experience of patients seen in neurology and surgery nursing clinics.
Objective: To evaluate the impact of health education provided by an APN on health literacy, self-efficacy, quality of life, and the experience of patients seen in a neurology and surgery nursing clinic.
Methods: A quasi-experimental, pre- and post-intervention, single-group study. The study will begin after approval by the relevant Ethics Committee. The intervention will consist of providing comprehensive, individualized health education that includes information on the person's health history, recommended lifestyle habits and practices, available treatment options, identification of warning signs and symptoms, how to respond appropriately to them, available care pathways, and contact information for the unit. Patients seen by a Primary Care Team (PCT) in neurology and surgery nursing consultations will be included, with data collected at three points in care: before the intervention, after the intervention, and at 6 months. The primary variable is health literacy, and secondary variables are self-efficacy, quality of life, and patient experience. A pre-post comparability analysis will be performed on the variables studied.
Relevance: The results will provide applicable evidence to promote organizational models that integrate PCTs into specialized care, improving the quality of care and the patient experience, and guiding future lines of research and implementation policies. In turn, they intend to demonstrate the value provided by the EPAs on the outcome indicators and the experience of the people attended in the neurology and surgery nursing consultations.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eulalia Gine-Cipres, MSc
- Numéro de téléphone: 2479 +34934 893 000
- E-mail: eulalia.gine@vallhebron.cat
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients referred for their first individualized health education visit at the Advanced Practice Nursing clinics in the Department of Neurosciences and Surgery, Vall d'Hebron University Hospital.
- Ability to provide written informed consent.
- Willingness to participate in the study.
Exclusion Criteria:
- Cognitive impairment preventing active participation in or understanding of the educational intervention and assessment questionnaires.
- Language barriers that prevent adequate understanding of the intervention or completion of the questionnaires.
- Failure to complete the pre- and post-intervention assessments
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Advanced Practice Nursing Model
|
The intervention will consist of providing comprehensive, individualized health education tailored to each specific health situation and condition. This health education will take place during routine healthcare visits and will include: information about the person's health status, recommended lifestyle habits and practices, available treatment options, identification of warning signs and symptoms and how to respond appropriately, available healthcare pathways, and contact information for the unit. The health education will be supplemented with printed materials to facilitate understanding and self-care at home. The duration of these visits varies depending on the individual's health condition and situation, typically ranging from 30 to 60 minutes. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Health literacy
Délai: Baseline, immediately after the intervention, and 6 months after the intervention.
|
Health literacy will be assessed using the 12-item Health Literacy Survey Questionnaire (HLS-Q12). Each item is scored on a 4-point Likert scale, ranging from 1 (very difficult) to 4 (very easy). The total score ranges from 12 to 48, with higher scores indicating better health literacy. |
Baseline, immediately after the intervention, and 6 months after the intervention.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Self-efficacy for managing chronic disease
Délai: Baseline, immediately after the intervention, and 6 months after the intervention.
|
Self-efficacy will be assessed using the 4-item Spanish version of the Self-Efficacy to Manage Chronic Disease Scale (SEMCD-S). Each item is scored from 1 (not at all confident) to 10 (totally confident). The overall score is calculated as the mean of the four items and ranges from 1 to 10, with higher scores indicating greater self-efficacy in managing chronic disease. |
Baseline, immediately after the intervention, and 6 months after the intervention.
|
|
Health-related quality of life
Délai: Baseline, immediately after the intervention, and 6 months after the intervention.
|
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey, Version 2 (SF-12v2). The questionnaire provides two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores will be calculated using norm-based scoring based on the 2009 US general population norms (mean 50, standard deviation 10). The theoretical score ranges are 9.9 to 76.0 for PCS and 3.2 to 77.9 for MCS, assuming complete data. Higher scores indicate better physical and mental health-related quality of life, respectively. |
Baseline, immediately after the intervention, and 6 months after the intervention.
|
|
Patient experience
Délai: Baseline, immediately after the intervention, and 6 months after the intervention.
|
Patient experience will be assessed using the Instrument for Evaluation of the Experience of Chronic Patients (IEXPAC). The questionnaire includes 11 core items scored on a 5-point Likert scale, with responses converted to values ranging from 0 to 10. The overall score is calculated as the mean of the 11 core items and ranges from 0 to 10, with higher scores indicating a better patient experience. Additional conditional items are scored separately and are not included in the overall score. |
Baseline, immediately after the intervention, and 6 months after the intervention.
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PR(AG)295/2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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