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

NCT07635537 | Not Yet Recruiting DMC

• 1 other identifier: 26/114-E
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Self-management; Medication Adherence

Keywords

Asthma; Nursing Diagnosis; Treatment Adherence and Compliance; Nursing Care; Digital Divide; Digital Technology; Artificial Intelligence; Structured nursing intervention; NANDA-I, NIC, NOC

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (6)

• Change in lung function (forced expiratory volume in the first second, FEV1)

  Baseline, month 6, and month 12

• Change in inhaler technique

  Baseline, month 3, month 6, and month 12

• Change in emotional health (Hospital Anxiety and Depression Scale, HADS)

  Month 1 and month 9

• Change in dietary habits (PREDIMED Mediterranean diet adherence questionnaire)

  Month 1 and month 9

• Change in health-related quality of life (EuroQol-5D-5L, EQ-5D-5L)

  Baseline and month 12

Other Outcomes (4)

• Participant retention

  12 months (baseline to month 12)

• Data completeness for the Asthma Control Test (ACT)

  12 months (baseline to month 12)

• Acceptability measured by the System Usability Scale (SUS)

  Month 12

Study Arms (1)

RESPiraIA-Asma structured nursing intervention

EXPERIMENTAL

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

Interventions

RESPiraIA-Asma BEHAVIORAL

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).

RESPiraIA-Asma structured nursing intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Significant respiratory comorbidity (chronic obstructive pulmonary disease ( COPD), bronchiectasis, pulmonary fibrosis, chronic pulmonary thromboembolism, or home oxygen therapy).
• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Instituto de Salud Carlos III: collaborator
• Universidad Nacional de Educación a Distancia (UNED): collaborator
• Instituto de Investigación Sanitaria San Carlos (IdISSC): collaborator

Study Sites (1)

Centro de Especialidades Modesto Lafuente (Hospital Clínico San Carlos)

Madrid, Spain

Location

Related Publications (3)

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.

  PMID: 26230150 BACKGROUND

• Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud. 2024 Jun;154:104705. doi: 10.1016/j.ijnurstu.2024.104705. Epub 2024 Feb 24.

  PMID: 38564982 BACKGROUND

MeSH Terms

Conditions

Asthma; Medication Adherence; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Behavior

Central Study Contacts

Elena Fariñas Álvarez, RN, MSc

CONTACT

34652114649; elena.farinas@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants receive the same structured nursing intervention, RESPiraIA-Asma, in a single-group, before-and-after design with no control group; comparisons are within-subject, from baseline to month 12. The intervention is delivered through three equivalent access modalities (digital, mixed, or in-person), assigned according to digital competence, internet access, available devices, and patient preference. These modalities are access channels only: the clinical content, including instruments, activation thresholds, and assessment time points, is identical across all of them, so they do not constitute separate study arms. Participants may change modality during follow-up if their circumstances change, and any change is recorded as a follow-up variable.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

ES (1)