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

Официальное название

Design and Development of RESPiraIA-Asthma: A Structured Nursing Intervention for the Follow-up of Adults With Poorly Controlled Asthma. A Pilot Study

Обзор

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.

Подробное описание

RESPiraIA-Asma is the first pilot application of the RESPiraIA model, a structured nursing intervention built on three operational cores. The administrative core covers governance and digital equity through three equivalent access routes (digital, mixed, and in-person). The clinical core triangulates asthma control and treatment adherence using three validated instruments: the Asthma Control Test (ACT) for clinical control, the Test of Adherence to Inhalers (TAI) for self-reported adherence, and the Medication Possession Ratio (MPR) for objective adherence from pharmacy dispensing, with automatic calculation of the discrepancy between self-reported and objective adherence as an active clinical indicator. The nursing core delivers a standardized 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.

The study sits within the development and feasibility phases of the Medical Research Council (MRC) framework for complex interventions. It is not a confirmatory efficacy trial; the clinical outcomes are evaluated as preliminary signals intended to inform the design of a future multicentre confirmatory trial. Pre-pilot functional verification of the data capture system, REDCap (Research Electronic Data Capture), was carried out using systematic synthetic profiles before the start of recruitment.

Вмешательства

• Поведенческое RESPiraIA-Asma
  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 Class

Первичные конечные точки

• Change in asthma control measured by the Asthma Control Test (ACT) [Срок оценки: Baseline, month 6, month 9, and month 12]
• Change in objective treatment adherence measured by the Medication Possession Ratio (MPR) [Срок оценки: 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) [Срок оценки: Month 1, month 6, month 9, and month 12]

Вторичные конечные точки (6)

• Change in lung function (forced expiratory volume in the first second, FEV1) [Срок оценки: Baseline, month 6, and month 12]
• Change in inhaler technique [Срок оценки: Baseline, month 3, month 6, and month 12]
• Change in emotional health (Hospital Anxiety and Depression Scale, HADS) [Срок оценки: Month 1 and month 9]
• Change in dietary habits (PREDIMED Mediterranean diet adherence questionnaire) [Срок оценки: Month 1 and month 9]
• Change in health-related quality of life (EuroQol-5D-5L, EQ-5D-5L) [Срок оценки: Baseline and month 12]
• Change in asthma knowledge (RESPiraIA-Knowledge questionnaire) [Срок оценки: Baseline and month 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Испания · 1 центр

• Centro de Especialidades Modesto Lafuente (Hospital Clínico San Carlos) — Madrid

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07635537 · 26/114-E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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