Severe AsthmaNCT06421402
K-HEALTH in AIR - Barcelona Pilot - Cohort
An observational study of Severe Asthma and COPD, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Severe Asthma, COPD
- What is being tested?
- Air quality monitoring at patient's home, Questionnaires: Baseline & every six months and Lung function Testing: Baseline & every six months & during exacerbations
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 13 Oct 2023to 31 Aug 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Dementia.
- Inability to perform independent daily activities.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
Barcelona, 08036
About this study
Official title: Knowledge for Improving Indoor Air Quality and Health: Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months.
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.
Read the 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):
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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)).
- Conditions
- Severe Asthma, COPD
- Being tested
- Air quality monitoring at patient's home, Questionnaires: Baseline & every six months, Lung function Testing: Baseline & every six months & during exacerbations, EMR & registry data, Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)
- Keywords
- Prevention of Unplanned Hospital Admissions, Nurse Case Manager, COPD, Severe Asthma, Integrated Care, Digital support, Indoor Air Quality
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air quality monitoring at patient's homeOther
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
Questionnaires: Baseline & every six monthsOther
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 to Inhalers (TAI-12); Asthma Quality of Life Questionnaire (mini AQLQ); Sino-Nasal Outcome Test (SNOT-22).
Lung function Testing: Baseline & every six months & during exacerbationsDiagnostic test
- 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.
EMR & registry dataOther
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).
Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)Device
Health Circuit: chat, short questionnaires (Likert scale). As needed.
Physiological data - Beat One WatchDevice
Enhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV))
Patient EmpowermentDevice
Mobile App Health Circuit: follow-up of the personalized action plan agreed with the patient \& reference doctor
Characteristics of exacerbationsOther
Health Circuit: home-based oscillometry, daily disease-specific questionnaire during the acute episode and continuous assessment of physiological variables.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up 200 high-risk chronic respiratory outpatients for 2 years. | The INTERVENTION (PHASE I, 2024) will have four components: i) Assessment of Lung Function Testing, ii) Monitoring of IAQ at patients' homes (and analysis of the relationships between IAQ and health events), iii) Evaluation of advanced digital support to a novel clinical process to enhance early identification and management of exacerbations (questionnaires, chat, patients' self-capturing sensors, and iv) Development, and refinement, of machine learning-based predictive modelling for supporting clinical decision making.
During PHASE II (2025), the INTERVENTION will consist of the assessment (Quintuple Aim) of the novel integrated care service, as well as the evaluation of its potential for scalability (CFIR).
See inclusion/exclusion criteria and planned measurements in the enclosed documents. Receives: Other: Air quality monitoring at patient's home; Other: Questionnaires: Baseline & every six months; Diagnostic Test: Lung function Testing: Baseline & every six months & during exacerbations; Other: EMR & registry data; Device: Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023); Device: Physiological data - Beat One Watch; Device: Patient Empowerment; Other: Characteristics of exacerbations | |
| Control Group | The control group will be introduced in Phase II (2025) to estimate the potential for healthcare value generation of the novel integrated care service. It will include patients with equivalent characteristics who receive standard of care practice, without the interventions carried out in the cohort group.
The control group will be shaped using 1-to-1 propensity score matching techniques. Data from the control group will be obtained from electronic medical records and registry information. In a randomly selected subset of 50 individuals from the control group a Quintuple Aim assessment will be done. Receives: Other: EMR & registry data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in use of healthcare resources - Unplanned hospital admissions
Number of unplanned hospital admissions.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Measured: During 2025
Changes in use of healthcare resources - Exacerbations
Number and severity of exacerbations.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Measured: During 2025
Changes in use of healthcare resources - Emergency room visits
Number of emergency room visits.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Measured: During 2025
Changes in use of healthcare resources - Primary care visits.
Number of primary care visits.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Measured: During 2025
Secondary outcomes (18)
Healthcare costs
Healthcare costs in €
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Measured: During 2025
Patient reported experience (PREMs) - Enjoyment of life
Enjoyment of life: ICEpop CAPability measure for Older people (ICECAP-O)
Scored on a scale from 0 to 1, where 0 represents no capability and 1 represents full capability.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Measured: During 2025
Patient reported experience (PREMs) - Resilience
Resilience: Brief Resilience Scale (BRS)
Scores range from 1 to 5, with higher scores indicating greater resilience.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Measured: During 2025
Patient reported experience (PREMs) - Physical functioning
Physical functioning: 36-Item Short Form Survey (SF-36)
Scores range from 0 to 100, where a higher score indicates better health status.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Measured: During 2025
Patient reported experience (PREMs) - Continuity of care
Continuity of care: Nijmegen Continuity Questionnaire (NCQ)
Scores ranging on a Likert scale from 1 to 5.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Measured: During 2025
Patient reported experience (PREMs) - Physiological wellbeing
Physiological wellbeing: Mental Health Inventory-5 (MHI-5)
Scored on a scale of 0 to 100, where higher scores indicate better mental health.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Measured: During 2025
Patient reported experience (PREMs) - Social Participation
Social Participation: Impact on Participation and Autonomy (IPA)
Uses a scoring system based on a Likert scale ranging from 0 to 4 where higher scores indicate greater impairment in participation and autonomy.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Measured: During 2025
Patient reported experience (PREMs) - Person-centeredness
Person-centeredness: Patient Perceptions of Patient-Centeredness Questionnaire (P3CEQ)
Typically uses a Likert scale from 1 to 5, with higher scores indicating better perceptions of patient-centeredness.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Measured: During 2025
Patient reported outcomes (PROMs) - Asthma symptoms
Asthma symptoms: Asthma Control Test (ACT)
5 questions, each scored from 1 (poor control of asthma) to 5 (complete control of asthma). Higher scores indicate better asthma control.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
*Depending on whether the primary disorder is asthma or COPD
Measured: During 2025
Patient reported outcomes (PROMs) - Functional problems related to asthma
Functional problems related to asthma: Asthma Quality of Life Questionnaire (miniAQLQ)
Designed to measure the functional problems (physical, emotional, social, and occupational) that are most troublesome to adults with asthma. It includes a series of questions scored from 1 (maximum impairment) to 7 (no impairment), with higher scores indicating better quality of life.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
*Depending on whether the primary disorder is asthma or COPD
Measured: During 2025
Patient reported outcomes (PROMs) - COPD symptoms
COPD symptoms: COPD Assessment Test (CAT)
Each question is scored from 0 (no impact) to 5 (maximum impact), with the total score ranging from 0 (less impact) to 40 (more impact), indicating the severity of COPD.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
*Depending on whether the primary disorder is asthma or COPD
Measured: During 2025
Patient reported outcomes (PROMs) - Dyspnea
Dyspnea: Modified Medical Research Council (mMRC) Dyspnea Scale.
It ranges from 0 (no breathlessness except with strenuous exercise) to 4 (too breathless to leave the house or breathless when dressing/undressing), with higher scores indicating more severe dyspnea.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
*Depending on whether the primary disorder is asthma or COPD
Measured: During 2025
Patient reported outcomes (PROMs) - Sino-Nasal symptoms
Sino-Nasal symptoms: Sino-Nasal Outcome Test (SNOT-22)
22 items, each scored from 0 (no problem) to 5 (problem as bad as it can be). The total score can thus range from 0 (no sinus-related health problems) to 110 (severe sinus-related health problems).
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
*Depending on whether the primary disorder is asthma or COPD
Measured: During 2025
Patient reported outcomes (PROMs) - Adherence to inhalers
Adherence to inhalers: Test of Adherence to Inhalers (TAI-12)
12-item questionnaire used to assess a patient's adherence to inhaler medication in respiratory diseases. Each item is scored on a 5-point scale, with higher scores indicating better adherence. The total score ranges from 12 (poor adherence) to 60 (excellent adherence).
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
*Depending on whether the primary disorder is asthma or COPD
Measured: During 2025
Equity of the intervention
Access to the service across different population groups: age, ethnicity, gender, socioeconomic status.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Measured: During 2025
Performance of Predictive Modeling for Enhanced Management of Exacerbations
Model accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve
Measured: During 2025
Performance of the digital support in terms of robustness and usability - Customer Satisfaction
Customer Satisfaction: Net Promoter Score (NPS)
Measures customer loyalty and satisfaction. It is derived from asking customers a single question on a 0-10 scale
Assessed in the intervention group only.
Measured: During 2025
Performance of the digital support in terms of robustness and usability - Usability
Usability: System Usability Scale (SUS)
Scored on a scale of 0 to 100, scores above 80 is an indicator of excellent usability, while a score below 60 could be problematic and suggests that the design needs improvements.
Assessed in the intervention group only.
Measured: During 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start13 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Josep Roca Torrent, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Investigators
- JOSEP ROCA TORRENT, MD, PHD, Principal investigator, Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421402
- Sponsor's protocol ID
- HCB/2023/0126
- Other IDs
- 101057693
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: During the entirety of the project, it is not allowed to disseminate data. Nonetheless, should a formal request be submitted, it may be permissible to disclose certain elements of the information, albeit not in its totality.
Publications
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.
PubMed 37314850Herranz 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.
PubMed 37972230Yamagami 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.
PubMed 29317813Wu 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.
PubMed 33955840Herranz 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.
PubMed 42386347Gomez-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/bmjresp-2024-002589.
PubMed 39837595
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge for Improving Indoor Air Quality and Health: Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months.
- ClinicalTrials.gov ID
- NCT06421402
- Acronym / sponsor ID
- HCB/2023/0126
- Conditions
- Severe Asthma, COPD
- Keywords
- Prevention of Unplanned Hospital Admissions, Nurse Case Manager, COPD, Severe Asthma, Integrated Care, Digital support, Indoor Air Quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i SunyerUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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)).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up 200 high-risk chronic respiratory outpatients for 2 years. | – | Other: Air quality monitoring at patient's home, Other: Questionnaires: Baseline & every six months, Diagnostic Test: Lung function Testing: Baseline & every six months & during exacerbations, Other: EMR & registry data, Device: Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023), Device: Physiological data - Beat One Watch, Device: Patient Empowerment, Other: Characteristics of exacerbationsThe INTERVENTION (PHASE I, 2024) will have four components: i) Assessment of Lung Function Testing, ii) Monitoring of IAQ at patients' homes (and analysis of the relationships between IAQ and health events), iii) Evaluation of advanced digital support to a novel clinical process to enhance early identification and management of exacerbations (questionnaires, chat, patients' self-capturing sensors, and iv) Development, and refinement, of machine learning-based predictive modelling for supporting clinical decision making. During PHASE II (2025), the INTERVENTION will consist of the assessment (Quintuple Aim) of the novel integrated care service, as well as the evaluation of its potential for scalability (CFIR). See inclusion/exclusion criteria and planned measurements in the enclosed documents. |
| Control Group | – | Other: EMR & registry dataThe control group will be introduced in Phase II (2025) to estimate the potential for healthcare value generation of the novel integrated care service. It will include patients with equivalent characteristics who receive standard of care practice, without the interventions carried out in the cohort group. The control group will be shaped using 1-to-1 propensity score matching techniques. Data from the control group will be obtained from electronic medical records and registry information. In a randomly selected subset of 50 individuals from the control group a Quintuple Aim assessment will be done. |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Dementia.
- Inability to perform independent daily activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air quality monitoring at patient's homeIndoor 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 | Other | Follow-up 200 high-risk chronic respiratory outpatients for 2 years. |
| Questionnaires: Baseline & every six monthsGeneral 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 to Inhalers (TAI-12); Asthma Quality of Life Questionnaire (mini AQLQ); Sino-Nasal Outcome Test (SNOT-22). | Other | Follow-up 200 high-risk chronic respiratory outpatients for 2 years. |
| 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. | Diagnostic test | Follow-up 200 high-risk chronic respiratory outpatients for 2 years. |
| EMR & registry dataElectronic 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). | Other | Control Group, Follow-up 200 high-risk chronic respiratory outpatients for 2 years. |
| Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)Health Circuit: chat, short questionnaires (Likert scale). As needed. | Device | Follow-up 200 high-risk chronic respiratory outpatients for 2 years. |
| Physiological data - Beat One WatchEnhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV)) | Device | Follow-up 200 high-risk chronic respiratory outpatients for 2 years. |
| Patient EmpowermentMobile App Health Circuit: follow-up of the personalized action plan agreed with the patient \& reference doctor | Device | Follow-up 200 high-risk chronic respiratory outpatients for 2 years. |
| Characteristics of exacerbationsHealth Circuit: home-based oscillometry, daily disease-specific questionnaire during the acute episode and continuous assessment of physiological variables. | Other | Follow-up 200 high-risk chronic respiratory outpatients for 2 years. |
Primary outcome
Changes in use of healthcare resources - Unplanned hospital admissions
Time frame: During 2025
Number of unplanned hospital admissions. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Changes in use of healthcare resources - Exacerbations
Time frame: During 2025
Number and severity of exacerbations. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Changes in use of healthcare resources - Emergency room visits
Time frame: During 2025
Number of emergency room visits. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Changes in use of healthcare resources - Primary care visits.
Time frame: During 2025
Number of primary care visits. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
18 secondary outcomes
Healthcare costs
Time frame: During 2025
Patient reported experience (PREMs) - Enjoyment of life
Time frame: During 2025
Patient reported experience (PREMs) - Resilience
Time frame: During 2025
Patient reported experience (PREMs) - Physical functioning
Time frame: During 2025
Patient reported experience (PREMs) - Continuity of care
Time frame: During 2025
Patient reported experience (PREMs) - Physiological wellbeing
Time frame: During 2025
Patient reported experience (PREMs) - Social Participation
Time frame: During 2025
Patient reported experience (PREMs) - Person-centeredness
Time frame: During 2025
Patient reported outcomes (PROMs) - Asthma symptoms
Time frame: During 2025
Patient reported outcomes (PROMs) - Functional problems related to asthma
Time frame: During 2025
Patient reported outcomes (PROMs) - COPD symptoms
Time frame: During 2025
Patient reported outcomes (PROMs) - Dyspnea
Time frame: During 2025
Patient reported outcomes (PROMs) - Sino-Nasal symptoms
Time frame: During 2025
Patient reported outcomes (PROMs) - Adherence to inhalers
Time frame: During 2025
Equity of the intervention
Time frame: During 2025
Performance of Predictive Modeling for Enhanced Management of Exacerbations
Time frame: During 2025
Performance of the digital support in terms of robustness and usability - Customer Satisfaction
Time frame: During 2025
Performance of the digital support in terms of robustness and usability - Usability
Time frame: During 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 37314850Herranz 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.
- BackgroundHerranz 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
- Background: PubMed 37972230Veneroni 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.
- Background: PubMed 29317813Yamagami 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.
- Background: PubMed 33955840Wu 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.
- BackgroundHerranz C. An Adaptive Case Management Approach to Prevent Unplanned Hospital Admissions in a Care Continuum Scenario. Published online 2023.
- Derived from this study: PubMed 42386347Gonzalez-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.
- Derived from this study: PubMed 39837595Gomez-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/bmjresp-2024-002589.
- EU PROJECT K-HEALTH IN AIRLink provided by the sponsor.
- IDIBAPS Members of \"Mecanismes fisiopatològics de les malalties respiratòries\"Link provided by the sponsor.
- Individual participant dataSharing planned: No. During the entirety of the project, it is not allowed to disseminate data. Nonetheless, should a formal request be submitted, it may be permissible to disclose certain elements of the information, albeit not in its totality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSEP ROCA TORRENT, MD, PHD principal investigator
Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma and COPD, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in use of healthcare resources - Unplanned hospital admissions (time frame: During 2025). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06421402, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.