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| ID | Type | Description | Link |
|---|---|---|---|
| 101057693 | Other Grant/Funding Number | HaDEA |
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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
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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.
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):
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:
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 ClĂnic de Barcelona (HCB-2023-0126)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air quality monitoring at patient's home | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | During 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During 2025 |
| Patient reported experience (PREMs) - Enjoyment of life |
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Inclusion Criteria:
Exclusion Criteria:
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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 ClĂnic de Barcelona, using a similar approach.
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| Name | Affiliation | Role |
|---|---|---|
| JOSEP ROCA TORRENT, MD, PHD | Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FundaciĂł de Recerca ClĂnic Barcelona - Institut d'InvestigaciĂł Biomèdica August Pi I Sunyer (FRCB-IDIBAPS) | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37314850 | Background | 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. | |
| Background | 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 | ||
| 37972230 |
| Label | URL |
|---|---|
| EU PROJECT K-HEALTH IN AIR | View source |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2023 | Apr 29, 2024 |
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| Questionnaires: Baseline & every six months | Other | General surveys:
Disease specific questionaires:
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| Lung function Testing: Baseline & every six months & during exacerbations | Diagnostic Test |
Ancillary measurements: Systemic arterial pressure and pulse oximetry. |
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| EMR & registry data | Other | 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). |
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| Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023) | Device | Health Circuit: chat, short questionnaires (Likert scale). As needed. |
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| Physiological data - Beat One Watch | Device | Enhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV)) |
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| Patient Empowerment | Device | Mobile App Health Circuit: follow-up of the personalized action plan agreed with the patient & reference doctor |
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| Characteristics of exacerbations | Other | Health Circuit: home-based oscillometry, daily disease-specific questionnaire during the acute episode and continuous assessment of physiological variables. |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | During 2025 |
| Background |
| 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. |
| 29317813 | Background | 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. |
| 33955840 | Background | 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. |
| Background | Herranz C. An Adaptive Case Management Approach to Prevent Unplanned Hospital Admissions in a Care Continuum Scenario. Published online 2023. |
| 42386347 | Derived | 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. |
| 39837595 | Derived | 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/bmjresp-2024-002589. |
| IDIBAPS Members of \"Mecanismes fisiopatològics de les malalties respiratòries\" | View source |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2023 | May 7, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000085143 | Routinely Collected Health Data |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D017530 | Health Care Quality, Access, and Evaluation |
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