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

3 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in asthma control measured by the Asthma Control Test (ACT)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in lung function (forced expiratory volume in the first second, FEV1)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Participant retention
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hospital San Carlos, Madrid

Współpracownicy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2029

Ukończenie studiów (Szacowany)

1 września 2029

Daty rejestracji na studia

Pierwszy przesłany

3 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

9 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 26/114-E

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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).

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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