- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Eulalia Gine-Cipres, MSc
- Puhelinnumero: 2479 +34934 893 000
- Sähköposti: eulalia.gine@vallhebron.cat
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Health literacy
Aikaikkuna: 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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Self-efficacy for managing chronic disease
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- PR(AG)295/2025
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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