Structured Nursing Intervention for Adults With Poorly Controlled Asthma: A Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital San Carlos, Madrid
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
RESPiraIA-Asma
BehavioralStructured 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).
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: RESPiraIA-Asma structured nursing interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 122
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 123
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 12Secondary outcomes
1
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 122
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 123
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 94
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 9Other outcomes
1
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)2
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)3
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 124
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 visitsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital San Carlos, Madrid
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Universidad Nacional de Educación a Distancia
Collaborator
Instituto de Investigación Sanitaria San Carlos (IdISSC)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: