Asthma, Medication Adherence, Self-management
Conditions
Keywords
Asthma, Nursing Diagnosis, Treatment Adherence and Compliance, Nursing Care, Digital Divide, Digital Technology, Artificial Intelligence, Structured nursing intervention, NANDA-I, NIC, NOC
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRESPiraIA-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).
Sponsors
Hospital San Carlos, Madrid
Instituto de Salud Carlos III
Universidad Nacional de Educación a Distancia (UNED)
Instituto de Investigación Sanitaria San Carlos (IdISSC)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
All participants receive the same structured nursing intervention, RESPiraIA-Asma, in a single-group, before-and-after design with no control group; comparisons are within-subject, from baseline to month 12. The intervention is delivered through three equivalent access modalities (digital, mixed, or in-person), assigned according to digital competence, internet access, available devices, and patient preference. These modalities are access channels only: the clinical content, including instruments, activation thresholds, and assessment time points, is identical across all of them, so they do not constitute separate study arms. Participants may change modality during follow-up if their circumstances change, and any change is recorded as a follow-up variable.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in asthma control measured by the Asthma Control Test (ACT) | 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. |
| Change in objective treatment adherence measured by the Medication Possession Ratio (MPR) | 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. |
| Change in self-reported treatment adherence measured by the Test of Adherence to Inhalers (TAI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in lung function (forced expiratory volume in the first second, FEV1) | 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. |
| Change in inhaler technique | 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. |
| Change in emotional health (Hospital Anxiety and Depression Scale, HADS) | 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. |
| Change in dietary habits (PREDIMED Mediterranean diet adherence questionnaire) | 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. |
| Change in health-related quality of life (EuroQol-5D-5L, EQ-5D-5L) | 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. |
| Change in asthma knowledge (RESPiraIA-Knowledge questionnaire) | 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). |
Countries
Spain
Contacts
CONTACTElena Fariñas Álvarez, RN, MSc
Outcome results
None listed