About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RESPiraIA-Asma
Treatment groups
Sponsors and collaborators
Hospital San Carlos, Madrid
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Universidad Nacional de Educación a Distancia
Collaborator
Instituto de Investigación Sanitaria San Carlos (IdISSC)
Collaborator