K-HEALTH in AIR - Barcelona Pilot - Cohort

Официальное название

Knowledge for Improving Indoor Air Quality and Health: Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months.

Обзор

The study protocol is part of the European (EU) project "Knowledge for improving indoor AIR quality and HEALTH" (K-HEALTHinAIR, 2022-2026 - registry 101057693), which focuses on enhancing our understanding of how poor indoor air quality (IAQ) affects human health. Specifically, the project aims to identify IAQ determinants of adverse health events and to explore the development of cost-effective strategies for the precise monitoring and improvement, of IAQ across Europe. With the current study protocol, the Barcelona Pilot, at the Integrated Health District of Barcelona-Esquerra (AISBE, 520 k citizens), is conducting a cohort study over a two-year period (January 2024 to December 2025) to explore the relationships between IAQ (assessment of chemical pollutants in patients' homes) and health status (acute episodes) in multimorbid patients with chronic respiratory diseases (asthma and Chronic Obstructive Pulmonary Disease - COPD) over a two-year period. The protocol investigates the effectiveness of customized interventions across four critical areas: i) Advanced lung function testing, ii) Continuous IAQ monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modeling for early identification and management of exacerbations. The ultimate objective is to design and evaluate an innovative integrated care service aiming at enhancing both IAQ and the management of multimorbid patients with chronic obstructive respiratory diseases, with focus on COPD and severe asthma.

Подробное описание

The study is structured as a comprehensive two-phase approach. From January to December 2024 (Phase I) the protocol focuses on the assessment, and refinement, of the four core components of the study: i) Enhanced lung function testing, ii) IAQ home monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modelling for early detection and management of exacerbations. The main outcome at the end of Phase I is the design of an innovative integrated care service aiming at enhanced management of exacerbations and reduction of unplanned hospitalizations in high-risk patients.

From January to December 2025 (Phase II), the protocol aims to refine the novel clinical process, including the four core components alluded to above, as well as to evaluate the potential for healthcare value generation and scalability/transferability of the new integrated care service.

PHASE I (2024):

1. Enhanced Lung Function Testing: Adoption of oscillometry (forced oscillation technique) to measure respiratory system resistance and reactance, as a complementary tool of forced spirometry, exploring its potential for patients' monitoring and management of exacerbations. 2. Continuous Monitoring of IAQ at patients' homes: Assessment of advanced monitoring systems in patients' homes to continuously track air quality parameters, enabling the identification of environmental triggers linked to respiratory exacerbations. 3. Advanced Digital Support to innovative clinical processes with a two-fold aim: i) patient's empowerment for self-management of his/her condition, and ii) enhancing the role of the nurse case manager for early detection and management of exacerbations promoting share care agreements between the patient and the reference doctor (primary care physician and/or specialist). To this end, adoption of an Adaptive Case Management (ACM) Approach constitutes a key element. 4. Predictive Modeling: Development, and refinement, of machine learning-based modelling for early detection and management exacerbations. Key input data in the modelling approach will be: i) Clinical information (symptoms, Patient Reported Outcome Measures - PROMs), ii) Lung function testing, and iii) Patient's self-capturing physiological data through wrist sensors (health rate, heart rate variability and physical activity). Moreover, the impact of IAQ monitoring in the modelling will be explored.

The implementation, and refinement, of the four components alluded to above, as well as the design of the novel integrated care service, will be done with active engagement of patients, healthcare professionals, and other stakeholders in a co-design process using the Plan-Do-Study-Act (PDSA) methodology. Two PDSA cycles, with a six-month duration each, will be undertaken during 2024.

PHASE II (2025):

From January to December 2025, two additional PDSA cycles (six-month duration each) are planned to cover the following objectives:

1. Refinement of the novel integrated care service for enhanced management of exacerbations, as well as the implementation and continuous assessment of the four core components described in PHASE I. 2. Assessment of the outcomes of the novel integrated care service using the Quintuple Aim framework, that is, considering: i) Healthcare outcomes, ii) PROMs/Patient Reported Expirence Measures (PREMs), iii) healthcare professionals' engagement, iv) operational costs, and v) assessing equity. Comparison with conventional care will be done using a propensity score matching to elaborate a control group. 3. Evaluation of the process of deployment of the service using the Consolidated Framework for Implementation Research (CFIR) to identify barriers/facilitators for achieving a sustainable adoption, target candidates for the novel service, as well as potential for service transferability to other sites.

At the end of PHASE II, a mature service design ready for adoption should be available. Besides fulfilment of the objectives of K-Health in Air, the key lessons learned in the two-years period should provide novel insights for enhanced management of chronic patients with multimorbid conditions.

(Enclosed find: i) the Patient's Informed Consent approved by the Ethics Committee, as well as ii) the study protocol approved by the Ethics Committee of the Hosptial Clínic de Barcelona (HCB-2023-0126)).

Вмешательства

• Другое Air quality monitoring at patient's home
  Indoor Air Quality: \- MICA-INBIOT system: temperature (ºC), humidity (%), CO2 (ppm), total Volatile Organic Ccompounds (VOCs) (ppb), Formaldehyde (µg/m3); and Particulate Matter (PM) 1/2.5/4/10 (µg/m3) Outdoor Air Quality: \- Aeris Weather platform: NO, NO2, NOx, SO2, SO3, CO, and PM10, all expressed in µg/m3
• Другое Questionnaires: Baseline & every six months
  General surveys: * PROMs: ICHOM Adult Set; encompassing Patient Reported Outcomes Measurement Information System (PROMIS 10), World Health Organization Wellbeing Index (WHO 5) and World Health Organization Disability Assessment Schedule (WHO-DAS 12) questionnaires. * PREMs: Patient-Reported Indicator Survey (PaRIS) Disease specific questionaires: * COPD: COPD Assessment Test (CAT); modified Medical Research Council (mMRC) Dyspnea scale. * Asthma: Asthma Control Test (ACT); Test of Adherence t
• Диагностический тест Lung function Testing: Baseline & every six months & during exacerbations
  * Forced Spirometry: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) * Forced Oscillation Technique: Impedance, resistance and reactance. Ancillary measurements: Systemic arterial pressure and pulse oximetry.
• Другое EMR & registry data
  Electronic Medical Records (EMRs): Updated every twelve months to track clinical events from Hospital and Primary Care databases. Registry data: from the Catalan Health Surveillance System (CHSS).
• Устройство Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)
  Health Circuit: chat, short questionnaires (Likert scale). As needed.
• Устройство Physiological data - Beat One Watch
  Enhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV))
• Устройство Patient Empowerment
  Mobile App Health Circuit: follow-up of the personalized action plan agreed with the patient \& reference doctor
• Другое Characteristics of exacerbations
  Health Circuit: home-based oscillometry, daily disease-specific questionnaire during the acute episode and continuous assessment of physiological variables.

Первичные конечные точки

• Changes in use of healthcare resources - Unplanned hospital admissions [Срок оценки: During 2025]
• Changes in use of healthcare resources - Exacerbations [Срок оценки: During 2025]
• Changes in use of healthcare resources - Emergency room visits [Срок оценки: During 2025]
• Changes in use of healthcare resources - Primary care visits. [Срок оценки: During 2025]

Вторичные конечные точки (12)

• Healthcare costs [Срок оценки: During 2025]
• Patient reported experience (PREMs) - Enjoyment of life [Срок оценки: During 2025]
• Patient reported experience (PREMs) - Resilience [Срок оценки: During 2025]
• Patient reported experience (PREMs) - Physical functioning [Срок оценки: During 2025]
• Patient reported experience (PREMs) - Continuity of care [Срок оценки: During 2025]
• Patient reported experience (PREMs) - Physiological wellbeing [Срок оценки: During 2025]
• Patient reported experience (PREMs) - Social Participation [Срок оценки: During 2025]
• Patient reported experience (PREMs) - Person-centeredness [Срок оценки: During 2025]
• Patient reported outcomes (PROMs) - Asthma symptoms [Срок оценки: During 2025]
• Patient reported outcomes (PROMs) - Functional problems related to asthma [Срок оценки: During 2025]
• Patient reported outcomes (PROMs) - COPD symptoms [Срок оценки: During 2025]
• Patient reported outcomes (PROMs) - Dyspnea [Срок оценки: During 2025]

Критерии участия

Критерии включения

• Aged Maximum 85 years
• Diagnosed with chronic obstructive pulmonary conditions such as COPD or treatment-resistant asthma.
• Exhibiting a high burden of co-morbidities, assessed above the 80th percentile of the regional risk stratification pyramid using Adjusted Morbidity Groups (AMG) scoring.
• Residing in Barcelona-Esquerra, except for treatment-resistant asthma patients, live in any district of the city of Barcelona.

Критерии исключения

• Dementia.
• Inability to perform independent daily activities.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunye — Barcelona

Публикации

• Herranz C, Martin-Moreno Banegas L, Dana Muzzio F, Siso-Almirall A, Roca J, Cano I. A Practice-Proven Adaptive Case Management Approach for Innovative Health Care Services (Health Circuit): Cluster Randomized Clinical Pilot and Descriptive Observational Study. J Med Internet Res. 2023 Jun 14;25:e47672. doi: 10.2196/47672. PMID 37314850
• Herranz C. A Co-Creation Process Toward Sustainable Adoption of Integrated Care for Prevention of Unplanned Hospitalizations. medRxiv. Published online January 1, 2023:2023.08.03.23293537. doi:10.1101/2023.08.03.23293537
• Veneroni C, Valach C, Wouters EFM, Gobbi A, Dellaca RL, Breyer MK, Hartl S, Sunanta O, Irvin CG, Schiffers C, Pompilio PP, Breyer-Kohansal R. Diagnostic Potential of Oscillometry: A Population-based Approach. Am J Respir Crit Care Med. 2024 Feb 15;209(4):444-453. doi: 10.1164/rccm.202306-0975OC. PMID 37972230
• Yamagami H, Tanaka A, Kishino Y, Mikuni H, Kawahara T, Ohta S, Yamamoto M, Suzuki S, Ohnishi T, Sagara H. Association between respiratory impedance measured by forced oscillation technique and exacerbations in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2017 Dec 22;13:79-89. doi: 10.2147/COPD.S146669. eCollection 2018. PMID 29317813
• Wu CT, Li GH, Huang CT, Cheng YC, Chen CH, Chien JY, Kuo PH, Kuo LC, Lai F. Acute Exacerbation of a Chronic Obstructive Pulmonary Disease Prediction System Using Wearable Device Data, Machine Learning, and Deep Learning: Development and Cohort Study. JMIR Mhealth Uhealth. 2021 May 6;9(5):e22591. doi: 10.2196/22591. PMID 33955840
• Herranz C. An Adaptive Case Management Approach to Prevent Unplanned Hospital Admissions in a Care Continuum Scenario. Published online 2023.
• Gonzalez-Colom R, Gomez-Lopez A, Aguado A, Soler N, Sanchez-Ruano N, Sorribes M, Montilla-Ibarra A, Figols M, Rodriguez A, Vela E, Piera-Jimenez J, Farre R, Roca J, Cano I, Fermoso J, Arismendi E. Should household air quality monitoring be considered in selected patients with asthma and COPD? BMJ Open Respir Res. 2026 Jul 1;13(1):e003899. doi: 10.1136/bmjresp-2025-003899. PMID 42386347
• Gomez-Lopez A, Arismendi E, Cano I, Farre R, Figols M, Hernandez C, Montilla-Ibarra A, Sanchez-Ruano N, Sanchez B, Siso-Almirall A, Sorribes M, Vela E, Piera-Jimenez J, Benavent J, Fermoso J, Roca J, Gonzalez-Colom R. Protocol for the enhanced management of multimorbid patients with COPD and severe asthma: role of indoor air quality. BMJ Open Respir Res. 2025 Jan 20;12(1):e002589. doi: 10.1136/bmj PMID 39837595

Идентификаторы

NCT: NCT06421402 · HCB/2023/0126 · 101057693

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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