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

Study acronym: RESPiraIA
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Publications: details revised at 3 of 3 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07635537
Lead Sponsor Hospital San Carlos, Madrid
Collaborators: Instituto de Salud Carlos III, Universidad Nacional de Educación a Distancia, Instituto de Investigación Sanitaria San Carlos (IdISSC)
Conditions
(from sponsor)
Asthma, Medication Adherence, Self-management
Related terms Asthma, Medication Adherence, Treatment Adherence and Compliance
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov