An interventional study of RESPiraIA-Asma in Asthma, Medication Adherence and Self-management, sponsored by Hospital San Carlos, Madrid. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hospital San Carlos, Madrid · Not applicable, Interventional, and Health services research
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 30 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Hospital San Carlos, Madrid is the lead sponsor of 74 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: RESPiraIA-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).
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
Participant retention
Proportion of participants completing follow-up from baseline to month 12. Feasibility threshold of at least 70% (at least 21 of 30 participants).
Time frame: 12 months (baseline to month 12)
Data completeness for the Asthma Control Test (ACT)
Proportion of valid, complete ACT forms across the follow-up period. Feasibility threshold of at least 80%.
Time frame: 12 months (baseline to month 12)
Acceptability measured by the System Usability Scale (SUS)
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.
Time frame: Month 12
Nursing workload (consultation time and contact modality)
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.
Time frame: Baseline to month 12, at each of the six visits
Plan to share: Yes — 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).
Supporting information: Study protocol
Time frame: Beginning after the study completion date (anticipated September 2029), with no planned end date.
Access criteria: Requests should be addressed to the corresponding author and assessed on a reasonable-request basis, subject to institutional approval and data protection requirements.
Start is estimated for Oct 2026; primary completion for Apr 2029, 30 months later.
Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 30 months is above that.
Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hospital San Carlos, Madrid