Structured Nursing Intervention for Adults With Poorly Controlled Asthma: A Pilot Study

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.

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.