NCT07635537Not yet recruiting
Structured Nursing Intervention for Adults With Poorly Controlled Asthma: A Pilot Study
Design and Development of RESPiraIA-Asthma: A Structured Nursing Intervention for the Follow-up of Adults With Poorly Controlled Asthma. A Pilot Study
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- Hospital San Carlos, Madrid
- Diseases
- Asthma
- NCT number
- NCT07635537
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Oct 2026 to the primary completion date, 30 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute asthma exacerbation within the 4 weeks before inclusion.
- Participation in another clinical trial within the previous 12 months.
Other illness
- Significant respiratory comorbidity (chronic obstructive pulmonary disease ( COPD), bronchiectasis, pulmonary fibrosis, chronic pulmonary thromboembolism, or home oxygen therapy).
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Especialidades Modesto Lafuente (Hospital Clínico San Carlos) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.