Structured Nursing Intervention for Adults With Poorly Controlled Asthma: A Pilot Study (RESPiraIA-Asma)
3 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Elena Fariñas Álvarez, RN, MSc
- Número de teléfono: 34652114649
- Correo electrónico: elena.farinas@salud.madrid.org
Ubicaciones de estudio
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Madrid, España
- Centro de Especialidades Modesto Lafuente (Hospital Clínico San Carlos)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in asthma control measured by the Asthma Control Test (ACT)
Periodo de tiempo: Baseline, month 6, month 9, and month 12
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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.
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Baseline, month 6, month 9, and month 12
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Change in objective treatment adherence measured by the Medication Possession Ratio (MPR)
Periodo de tiempo: Baseline, month 1, month 6, month 9, and month 12
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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.
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Baseline, month 1, month 6, month 9, and month 12
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Change in self-reported treatment adherence measured by the Test of Adherence to Inhalers (TAI)
Periodo de tiempo: Month 1, month 6, month 9, and month 12
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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.
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Month 1, month 6, month 9, and month 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in lung function (forced expiratory volume in the first second, FEV1)
Periodo de tiempo: Baseline, month 6, and month 12
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Lung function measured by spirometry and expressed as the forced expiratory volume in the first second (FEV1) as a percentage of the predicted value.
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Baseline, month 6, and month 12
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Change in inhaler technique
Periodo de tiempo: Baseline, month 3, month 6, and month 12
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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.
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Baseline, month 3, month 6, and month 12
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Change in emotional health (Hospital Anxiety and Depression Scale, HADS)
Periodo de tiempo: Month 1 and month 9
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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.
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Month 1 and month 9
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Change in dietary habits (PREDIMED Mediterranean diet adherence questionnaire)
Periodo de tiempo: Month 1 and month 9
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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.
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Month 1 and month 9
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Change in health-related quality of life (EuroQol-5D-5L, EQ-5D-5L)
Periodo de tiempo: Baseline and month 12
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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.
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Baseline and month 12
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Change in asthma knowledge (RESPiraIA-Knowledge questionnaire)
Periodo de tiempo: Baseline and month 12
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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).
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Baseline and month 12
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Participant retention
Periodo de tiempo: 12 months (baseline to month 12)
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Proportion of participants completing follow-up from baseline to month 12. Feasibility threshold of at least 70% (at least 21 of 30 participants).
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12 months (baseline to month 12)
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Data completeness for the Asthma Control Test (ACT)
Periodo de tiempo: 12 months (baseline to month 12)
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Proportion of valid, complete ACT forms across the follow-up period.
Feasibility threshold of at least 80%.
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12 months (baseline to month 12)
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Acceptability measured by the System Usability Scale (SUS)
Periodo de tiempo: Month 12
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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.
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Month 12
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Nursing workload (consultation time and contact modality)
Periodo de tiempo: Baseline to month 12, at each of the six visits
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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.
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Baseline to month 12, at each of the six visits
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.
- Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud. 2024 Jun;154:104705. doi: 10.1016/j.ijnurstu.2024.104705. Epub 2024 Feb 24.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de abril de 2029
Finalización del estudio (Estimado)
1 de septiembre de 2029
Fechas de registro del estudio
Enviado por primera vez
3 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2026
Publicado por primera vez (Actual)
9 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Comportamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Asma
- Adherencia a la medicación
- Adherencia y Cumplimiento del Tratamiento
Otros números de identificación del estudio
- 26/114-E
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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).
Marco de tiempo para compartir IPD
Beginning after the study completion date (anticipated September 2029), with no planned end date.
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre RESPiraIA-Asma
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RespirAI US IncAún no reclutandoExacerbación de la EPOCEstados Unidos
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Duquesne UniversityPennsylvania Department of HealthTerminadoHipertensión | Obesidad | AsmaEstados Unidos
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Johns Hopkins UniversityNational Institute of Nursing Research (NINR)Terminado
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Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)Aún no reclutando
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Ann & Robert H Lurie Children's Hospital of ChicagoTerminadoAtaque asmáticoEstados Unidos
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Restech SrlReclutamientoAsmaItalia, Australia, Francia
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Columbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminadoDormir | Asma | Asma en niñosEstados Unidos
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National Institute of Nursing Research (NINR)National Institutes of Health (NIH)Terminado
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University of South FloridaNational Heart, Lung, and Blood Institute (NHLBI)ReclutamientoAsma crónicaEstados Unidos
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Rush University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); GlaxoSmithKlineTerminado