Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06421402

K-HEALTH in AIR - Barcelona Pilot - Cohort

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Severe Asthma Asthma Bronchial Diseases COPD Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

Up to 85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)

Barcelona, 08036, Spain

About this study

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)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Questionnaires: Baseline & every six months

Other

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 exacerbations

Diagnostic 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 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).

Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)

Device

Health Circuit: chat, short questionnaires (Likert scale). As needed.

Physiological data - Beat One Watch

Device

Enhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV))

Patient Empowerment

Device

Mobile App Health Circuit: follow-up of the personalized action plan agreed with the patient & reference doctor

Characteristics of exacerbations

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Healthcare costs

    Time frame: During 2025

    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

  2. Patient reported experience (PREMs) - Enjoyment of life

    Time frame: During 2025

    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.

  3. Patient reported experience (PREMs) - Resilience

    Time frame: During 2025

    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.

  4. Patient reported experience (PREMs) - Physical functioning

    Time frame: During 2025

    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.

  5. Patient reported experience (PREMs) - Continuity of care

    Time frame: During 2025

    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.

  6. Patient reported experience (PREMs) - Physiological wellbeing

    Time frame: During 2025

    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.

  7. Patient reported experience (PREMs) - Social Participation

    Time frame: During 2025

    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.

  8. Patient reported experience (PREMs) - Person-centeredness

    Time frame: During 2025

    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.

  9. Patient reported outcomes (PROMs) - Asthma symptoms

    Time frame: During 2025

    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

  10. Patient reported outcomes (PROMs) - Functional problems related to asthma

    Time frame: During 2025

    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

  11. Patient reported outcomes (PROMs) - COPD symptoms

    Time frame: During 2025

    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

  12. Patient reported outcomes (PROMs) - Dyspnea

    Time frame: During 2025

    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

  13. Patient reported outcomes (PROMs) - Sino-Nasal symptoms

    Time frame: During 2025

    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

  14. Patient reported outcomes (PROMs) - Adherence to inhalers

    Time frame: During 2025

    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

  15. Equity of the intervention

    Time frame: During 2025

    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

  16. Performance of Predictive Modeling for Enhanced Management of Exacerbations

    Time frame: During 2025

    Model accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve

  17. Performance of the digital support in terms of robustness and usability - Customer Satisfaction

    Time frame: During 2025

    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.

  18. Performance of the digital support in terms of robustness and usability - Usability

    Time frame: During 2025

    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.

Sponsors and collaborators

Lead sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 20, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.