ClinicalTrials.gg
Not yet recruitingNCT07880613APN-HEALTHUpdated Oct 19, 2026

Effectiveness of an Advanced Practice Nurse-Led Health Education Program (APN-HEALTH)

An interventional study of Individualized Health Education Program in Neurology, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Health services research

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Neurology
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In context

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 275 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Advanced Practice Nursing Model

    Behavioral: Individualized Health Education Program

Interventions

  • BehavioralIndividualized Health Education Program

    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.

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What researchers measure

Primary outcomes

  1. Health literacy

    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.

    Time frame: Baseline, immediately after the intervention, and 6 months after the intervention.

Secondary outcomes

  1. Self-efficacy for managing chronic disease

    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.

    Time frame: Baseline, immediately after the intervention, and 6 months after the intervention.

  2. Health-related quality of life

    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.

    Time frame: Baseline, immediately after the intervention, and 6 months after the intervention.

  3. Patient experience

    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.

    Time frame: Baseline, immediately after the intervention, and 6 months after the intervention.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07880613
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 19, 2026

Study contacts

Eulalia Gine-Cipres, MSc
Contact
eulalia.gine@vallhebron.cat
+34934 893 000 ext. 2479

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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