Not Yet RecruitingNot Applicable

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

Spain30 participantsStarted 2026-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is described as a pilot study with a phase listed as 'NA' — does that mean it's more about testing whether the intervention works in a small group before a larger trial, and what does that mean for how much is already known about whether it helps?
2The trial measures asthma control using something called the Asthma Control Test — based on my current ACT score, do you think my asthma is poorly controlled enough that I'd likely be a candidate for this kind of study?
3The study focuses on a structured nursing intervention for medication adherence and self-management — compared to what I'm doing now, could this type of support realistically improve how well I'm managing my inhalers day to day?
4Since the trial is not yet recruiting, how long might it be before it opens, and in the meantime, are there existing programs or standard-of-care options that offer similar nursing-led asthma education I could start sooner?
5The trial tracks both how often I actually fill my inhaler prescriptions and how I report using them — do you think a gap between those two measures might reveal something specific about where I'm struggling with my treatment routine?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in asthma control measured by the Asthma Control Test (ACT)

Timeframe: Baseline, month 6, month 9, and month 12

Change in objective treatment adherence measured by the Medication Possession Ratio (MPR)

Timeframe: 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)

Timeframe: Month 1, month 6, month 9, and month 12

Trial details

NCT IDNCT07635537

SponsorHospital San Carlos, Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04

Contact for this trial

Elena Fariñas Álvarez, RN, MSc

34652114649 elena.farinas@salud.madrid.org

View on ClinicalTrials.gov More Asthma trials