- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Eulalia Gine-Cipres, MSc
- Numero di telefono: 2479 +34934 893 000
- Email: eulalia.gine@vallhebron.cat
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health literacy
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Self-efficacy for managing chronic disease
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- PR(AG)295/2025
Piano per i dati dei singoli partecipanti (IPD)
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