Clinical trial NCT06421402: K-HEALTH in AIR - Barcelona Pilot - Cohort
Official title: Knowledge for Improving Indoor Air Quality and Health: Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Severe Asthma
COPD
Keywords: Prevention of Unplanned Hospital Admissions
Nurse Case Manager
COPD
Severe Asthma
Integrated Care
Digital support
Indoor Air Quality
Lead sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2024-05-20
Enrollment: 200
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is recruiting 80% of participants from seven AISBE primary care facilities, each serving around 20,000 people. Recruitment leverages Catalan Health Surveillance System data to identify potential participants and link them with their primary care physicians, who engage with patients to assess participation willingness and ensure contact throughout follow-up. Initial contact involves a phone call from a nurse case manager to introduce the project and set up a home visit.

The remaining 20% of the cohort, consisting of patients with treatment-resistant asthma, are recruited from the outpatient Severe Asthma Clinics at Hospital Clínic de Barcelona, using a similar approach.

Brief summary: 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.

Detailed description: 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)).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Dementia.
* Inability to perform independent daily activities.

Primary outcomes:
measure: Changes in use of healthcare resources - Unplanned hospital admissions
timeFrame: During 2025
measure: Changes in use of healthcare resources - Exacerbations
timeFrame: During 2025
measure: Changes in use of healthcare resources - Emergency room visits
timeFrame: During 2025
measure: Changes in use of healthcare resources - Primary care visits.
timeFrame: During 2025
Secondary outcomes:
measure: Healthcare costs
timeFrame: During 2025
measure: Patient reported experience (PREMs) - Enjoyment of life
timeFrame: During 2025
measure: Patient reported experience (PREMs) - Resilience
timeFrame: During 2025
measure: Patient reported experience (PREMs) - Physical functioning
timeFrame: During 2025
measure: Patient reported experience (PREMs) - Continuity of care
timeFrame: During 2025
measure: Patient reported experience (PREMs) - Physiological wellbeing
timeFrame: During 2025
measure: Patient reported experience (PREMs) - Social Participation
timeFrame: During 2025
measure: Patient reported experience (PREMs) - Person-centeredness
timeFrame: During 2025
measure: Patient reported outcomes (PROMs) - Asthma symptoms
timeFrame: During 2025
measure: Patient reported outcomes (PROMs) - Functional problems related to asthma
timeFrame: During 2025
measure: Patient reported outcomes (PROMs) - COPD symptoms
timeFrame: During 2025
measure: Patient reported outcomes (PROMs) - Dyspnea
timeFrame: During 2025
measure: Patient reported outcomes (PROMs) - Sino-Nasal symptoms
timeFrame: During 2025
measure: Patient reported outcomes (PROMs) - Adherence to inhalers
timeFrame: During 2025
measure: Equity of the intervention
timeFrame: During 2025
measure: Performance of Predictive Modeling for Enhanced Management of Exacerbations
timeFrame: During 2025
measure: Performance of the digital support in terms of robustness and usability - Customer Satisfaction
timeFrame: During 2025
measure: Performance of the digital support in terms of robustness and usability - Usability
timeFrame: During 2025
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
Study officials:
affiliation: Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
name: JOSEP ROCA TORRENT, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: Herranz C. An Adaptive Case Management Approach to Prevent Unplanned Hospital Admissions in a Care Continuum Scenario. Published online 2023.