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Structured Nursing Intervention for Adults With Poorly Controlled Asthma: A Pilot Study (RESPiraIA-Asma)

3 giugno 2026 aggiornato da: Elena Fariñas Álvarez, Hospital San Carlos, Madrid

Design and Development of RESPiraIA-Asthma: A Structured Nursing Intervention for the Follow-up of Adults With Poorly Controlled Asthma. A Pilot Study

Asthma affects a large number of adults, and many of them do not achieve good control of their symptoms. Poor inhaler technique, irregular medication use, and the lack of structured nursing follow-up are among the main reasons. RESPiraIA-Asma is a 12-month structured nursing intervention designed to address these gaps in adults with poorly controlled, non-severe asthma.

This is a quasi-experimental, single-group, before-and-after pilot study. Each participant is followed across six visits over one year, at baseline and at months 1, 3, 6, 9, and 12. The intervention combines therapeutic education, inhaler technique training, home peak-flow self-monitoring, biopsychosocial assessment, and a standardized nursing care plan based on internationally recognized nursing taxonomies for diagnoses, interventions, and outcomes: NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC), activated by objective clinical thresholds.

A central principle of the model is digital equity: the same standard of care is offered through three equivalent access routes (digital, mixed, or in-person), chosen according to each participant's digital skills, resources, and preferences, so that technology never becomes a barrier to access.

The study evaluates whether the model is feasible to deliver in routine clinical practice, measured through participant retention, data completeness, and acceptability, and it looks for preliminary signals of its effect on asthma control, treatment adherence, lung function, and biopsychosocial well-being. As an exploratory pilot, it is not designed to confirm efficacy; its purpose is to inform the design of a larger future trial.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

RESPiraIA-Asma is the first pilot application of the RESPiraIA model, a structured nursing intervention built on three operational cores. The administrative core covers governance and digital equity through three equivalent access routes (digital, mixed, and in-person). The clinical core triangulates asthma control and treatment adherence using three validated instruments: the Asthma Control Test (ACT) for clinical control, the Test of Adherence to Inhalers (TAI) for self-reported adherence, and the Medication Possession Ratio (MPR) for objective adherence from pharmacy dispensing, with automatic calculation of the discrepancy between self-reported and objective adherence as an active clinical indicator. The nursing core delivers a standardized care plan based on internationally recognized nursing taxonomies for diagnoses, interventions, and outcomes: NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC), activated by objective clinical thresholds.

The study sits within the development and feasibility phases of the Medical Research Council (MRC) framework for complex interventions. It is not a confirmatory efficacy trial; the clinical outcomes are evaluated as preliminary signals intended to inform the design of a future multicentre confirmatory trial. Pre-pilot functional verification of the data capture system, REDCap (Research Electronic Data Capture), was carried out using systematic synthetic profiles before the start of recruitment.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Spagna
      • Madrid, Spagna
        • Centro de Especialidades Modesto Lafuente (Hospital Clínico San Carlos)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Confirmed diagnosis of mild or moderate persistent, non-severe asthma.
  • Poorly controlled asthma, defined as an Asthma Control Test (ACT) score below 20.
  • Active inhaled maintenance therapy with inhaled corticosteroids (ICS), alone or combined with a long-acting beta-agonist (LABA).
  • Age 18 years or older.
  • Active follow-up in the Pulmonology outpatient clinic of Hospital Clínico San Carlos.
  • Sufficient cognitive capacity to participate and complete the questionnaires.
  • Access to a means of communication (in-person, telephone, digital, or mixed).
  • Signed informed consent.

Exclusion Criteria:

  • Significant respiratory comorbidity (chronic obstructive pulmonary disease ( COPD), bronchiectasis, pulmonary fibrosis, chronic pulmonary thromboembolism, or home oxygen therapy).
  • Acute asthma exacerbation within the 4 weeks before inclusion.
  • Participation in another clinical trial within the previous 12 months.
  • Cognitive impairment or language barriers preventing completion of the questionnaires.
  • Conditions limiting continuity of follow-up over the 12 months.
  • Mild comorbidities such as allergic rhinitis or mild sleep apnea are not exclusion criteria.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

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
Sperimentale: RESPiraIA-Asma structured nursing intervention
Single experimental arm: all enrolled participants receive the RESPiraIA-Asma intervention, with no control group, and comparisons are within-subject (baseline versus month 12). Follow-up lasts 12 months across six visits (baseline and months 1, 3, 6, 9, and 12). Each participant is assigned to one of three equivalent access modalities (digital, mixed, or in-person) according to digital competence, internet access, available devices, and preference. The clinical content is identical across modalities, and participants may switch modality during follow-up if their circumstances change.
Comportamentale: RESPiraIA-Asma
Structured nursing intervention of 12 months organized in three operational cores (administrative, clinical, and nursing) and delivered across six visits. It combines therapeutic education, inhaler technique training with the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) checklist, home peak-flow self-monitoring, biopsychosocial assessment, and a standardized care plan based on the NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC) taxonomies, activated by objective clinical thresholds. Treatment adherence is monitored through the triangulation of the Asthma Control Test (ACT), the Test of Adherence to Inhalers (TAI), and the Medication Possession Ratio (MPR). Follow-up and the deterministic care logic run in REDCap (Research Electronic Data Capture).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in asthma control measured by the Asthma Control Test (ACT)
Lasso di tempo: Baseline, month 6, month 9, and month 12
Asthma control assessed with the Asthma Control Test (ACT), a 5-item questionnaire scored from 5 to 25. The main analysis is the within-subject change from baseline to month 12, with a minimal clinically important difference of at least 3 points. The ACT is also the continuous variable used for the sample size calculation.
Baseline, month 6, month 9, and month 12
Change in objective treatment adherence measured by the Medication Possession Ratio (MPR)
Lasso di tempo: Baseline, month 1, month 6, month 9, and month 12
Objective adherence to inhaled maintenance therapy, calculated from pharmacy dispensing records as medication dispensed divided by medication prescribed, expressed as a percentage. A value of at least 80% is considered adequate. In participants with recent treatment initiation (less than 6 months), the ratio is not computable at baseline and adherence is assessed through the Test of Adherence to Inhalers (TAI) and inhaler technique.
Baseline, month 1, month 6, month 9, and month 12
Change in self-reported treatment adherence measured by the Test of Adherence to Inhalers (TAI)
Lasso di tempo: Month 1, month 6, month 9, and month 12
Self-reported adherence assessed with the Test of Adherence to Inhalers (TAI), a 12-item questionnaire; a score of at least 50 indicates good adherence. It is first administered at month 1 because it evaluates adherence behaviour over a prior treatment period, not applicable at baseline.
Month 1, month 6, month 9, and month 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in lung function (forced expiratory volume in the first second, FEV1)
Lasso di tempo: Baseline, month 6, and month 12
Lung function measured by spirometry and expressed as the forced expiratory volume in the first second (FEV1) as a percentage of the predicted value.
Baseline, month 6, and month 12
Change in inhaler technique
Lasso di tempo: Baseline, month 3, month 6, and month 12
Inhaler technique assessed by direct observation using the 8-step checklist of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR), recorded as the number of correctly performed steps out of 8.
Baseline, month 3, month 6, and month 12
Change in emotional health (Hospital Anxiety and Depression Scale, HADS)
Lasso di tempo: Month 1 and month 9
Emotional health assessed with the Hospital Anxiety and Depression Scale (HADS), with anxiety and depression subscales each scored from 0 to 21. Change analysed from month 1 to month 9.
Month 1 and month 9
Change in dietary habits (PREDIMED Mediterranean diet adherence questionnaire)
Lasso di tempo: Month 1 and month 9
Adherence to the Mediterranean diet assessed with the 14-item PREDIMED questionnaire; a score of at least 9 indicates good dietary adherence. Change analysed from month 1 to month 9.
Month 1 and month 9
Change in health-related quality of life (EuroQol-5D-5L, EQ-5D-5L)
Lasso di tempo: Baseline and month 12
Health-related quality of life assessed with the EuroQol-5D-5L (EQ-5D-5L), covering five health dimensions with five severity levels each, plus a visual analogue scale.
Baseline and month 12
Change in asthma knowledge (RESPiraIA-Knowledge questionnaire)
Lasso di tempo: Baseline and month 12
Functional knowledge about asthma and its management assessed with the RESPiraIA-Knowledge questionnaire, a 12-item instrument developed for this study, content-validated by an expert panel (scale-level content validity index, average, of 0.97).
Baseline and month 12

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant retention
Lasso di tempo: 12 months (baseline to month 12)
Proportion of participants completing follow-up from baseline to month 12. Feasibility threshold of at least 70% (at least 21 of 30 participants).
12 months (baseline to month 12)
Data completeness for the Asthma Control Test (ACT)
Lasso di tempo: 12 months (baseline to month 12)
Proportion of valid, complete ACT forms across the follow-up period. Feasibility threshold of at least 80%.
12 months (baseline to month 12)
Acceptability measured by the System Usability Scale (SUS)
Lasso di tempo: Month 12
Acceptability and usability of the program assessed with the System Usability Scale (SUS) in the digital and mixed modalities, complemented by a brief satisfaction questionnaire.
Month 12
Nursing workload (consultation time and contact modality)
Lasso di tempo: Baseline to month 12, at each of the six visits
Duration of each nursing consultation and type of contact (in-person, telephone, video, or mixed) recorded at every visit, to quantify the real care workload of the model.
Baseline to month 12, at each of the six visits

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital San Carlos, Madrid

Collaboratori

Instituto de Salud Carlos III
Universidad Nacional de Educación a Distancia (UNED)
Instituto de Investigación Sanitaria San Carlos (IdISSC)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 aprile 2029

Completamento dello studio (Stimato)

1 settembre 2029

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26/114-E

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data underlying the published results will be made available, including the clinical, adherence, and biopsychosocial outcome variables collected during the study (asthma control, treatment adherence, lung function, inhaler technique, emotional health, dietary habits, quality of life, and asthma knowledge). Data will be shared upon reasonable request to the corresponding author, after the end of the follow-up period, in accordance with the FAIR principles and EU data protection regulation (GDPR).

Periodo di condivisione IPD

Beginning after the study completion date (anticipated September 2029), with no planned end date.

Criteri di accesso alla condivisione IPD

Requests should be addressed to the corresponding author and assessed on a reasonable-request basis, subject to institutional approval and data protection requirements.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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