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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
30
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).
Centro de Especialidades Modesto Lafuente (Hospital Clínico San Carlos)
Madrid, Spain
Change in asthma control measured by the Asthma Control Test (ACT)
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.
Time frame: Baseline, month 6, month 9, and month 12
Change in objective treatment adherence measured by the Medication Possession Ratio (MPR)
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.
Time frame: 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)
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.
Time frame: Month 1, month 6, month 9, and month 12
Change in lung function (forced expiratory volume in the first second, FEV1)
Lung function measured by spirometry and expressed as the forced expiratory volume in the first second (FEV1) as a percentage of the predicted value.
Time frame: Baseline, month 6, and month 12
Change in inhaler technique
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.
Time frame: Baseline, month 3, month 6, and month 12
Change in emotional health (Hospital Anxiety and Depression Scale, HADS)
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.
Time frame: Month 1 and month 9
Change in dietary habits (PREDIMED Mediterranean diet adherence questionnaire)
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.
Time frame: Month 1 and month 9
Change in health-related quality of life (EuroQol-5D-5L, EQ-5D-5L)
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.
Time frame: Baseline and month 12
Change in asthma knowledge (RESPiraIA-Knowledge questionnaire)
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).
Time frame: Baseline and month 12
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