NeurologyAPN-HEALTHNCT07880613
Effectiveness of an Advanced Practice Nurse-Led Health Education Program (APN-HEALTH)
A study testing Individualized Health Education Program in people with Neurology, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurology
- What is being tested?
- Individualized Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Neurology
- Being tested
- Individualized Health Education Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Health Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Practice Nursing Model | Experimental | Not described Receives: Behavioral: Individualized Health Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after the intervention, and 6 months after the intervention.
Secondary outcomes (3)
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.
Measured: Baseline, immediately after the intervention, and 6 months after the intervention.
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.
Measured: Baseline, immediately after the intervention, and 6 months after the intervention.
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.
Measured: Baseline, immediately after the intervention, and 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurologyStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group interventional study in which all enrolled participants receive care according to the Advanced Practice Nursing model. Outcomes are assessed at baseline, immediately after the intervention, and at 6-month follow-up.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880613
- Sponsor's protocol ID
- PR(AG)295/2025
- Acronym
- APN-HEALTH
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07880613
- Acronym / sponsor ID
- APN-HEALTH / PR(AG)295/2025
- Conditions
- Neurology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group interventional study in which all enrolled participants receive care according to the Advanced Practice Nursing model. Outcomes are assessed at baseline, immediately after the intervention, and at 6-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Advanced Practice Nursing Model | Experimental | Behavioral: Individualized Health Education Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Health Education ProgramThe 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. | Behavioural | Advanced Practice Nursing Model |
Primary outcome
Health literacy
Time frame: 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.
3 secondary outcomes
Self-efficacy for managing chronic disease
Time frame: Baseline, immediately after the intervention, and 6 months after the intervention.
Health-related quality of life
Time frame: Baseline, immediately after the intervention, and 6 months after the intervention.
Patient experience
Time frame: Baseline, immediately after the intervention, and 6 months after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Health Education Program in people with Neurology, run by Hospital Universitari Vall d'Hebron Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eulalia Gine-Cipres, MSc (+34934 893 000 ext. 2479, eulalia.gine@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy (time frame: Baseline, immediately after the intervention, and 6 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.