K-HEALTH in AIR - Barcelona Pilot - Cohort

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06421402
• Other study ID #: HCB/2023/0126
• Secondary ID: 101057693
• Status: Enrolling by invitation
• Start date: October 13, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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)).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• COPD
• Severe Asthma

Intervention

Other:
• 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
• 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 to Inhalers (TAI-12); Asthma Quality of Life Questionnaire (mini AQLQ); Sino-Nasal Outcome Test (SNOT-22).

Diagnostic Test:
• 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.

Other:
• 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).

Device:
• Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)
Health Circuit: chat, short questionnaires (Likert scale). As needed.
• Physiological data - Beat One Watch
Enhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV))
• Patient Empowerment
Mobile App Health Circuit: follow-up of the personalized action plan agreed with the patient & reference doctor

Other:
• Characteristics of exacerbations
Health Circuit: home-based oscillometry, daily disease-specific questionnaire during the acute episode and continuous assessment of physiological variables.

Locations

Country	Name	City	State
Spain	Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut d'Investigacions Biomèdiques August Pi i Sunyer	Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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

Herranz C. An Adaptive Case Management Approach to Prevent Unplanned Hospital Admissions in a Care Continuum Scenario. Published online 2023.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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.	During 2025
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   EU PROJECT K-HEALTH IN AIR
•   IDIBAPS Members of "Mecanismes fisiopatològics de les malalties respiratòries"