K-HEALTH in AIR - Barcelona Pilot - Cohort
- Conditions
- Severe AsthmaCOPD
- Interventions
- Other: Air quality monitoring at patient's homeOther: EMR & registry dataDevice: Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)Device: Physiological data - Beat One WatchDevice: Patient EmpowermentOther: Characteristics of exacerbations
- Registration Number
- NCT06421402
- Brief Summary
The study protocol is part of the European (EU) project "Knowledge for improving indoor AIR quality and HEALTH" (K-HEALTHinAIR, 2022-2026 - registry 101057693), which focuses on enhancing our understanding of how poor indoor air quality (IAQ) affects human health. Specifically, the project aims to identify IAQ determinants of adverse health events and to explore the development of cost-effective strategies for the precise monitoring and improvement, of IAQ across Europe.
With the current study protocol, the Barcelona Pilot, at the Integrated Health District of Barcelona-Esquerra (AISBE, 520 k citizens), is conducting a cohort study over a two-year period (January 2024 to December 2025) to explore the relationships between IAQ (assessment of chemical pollutants in patients' homes) and health status (acute episodes) in multimorbid patients with chronic respiratory diseases (asthma and Chronic Obstructive Pulmonary Disease - COPD) over a two-year period.
The protocol investigates the effectiveness of customized interventions across four critical areas: i) Advanced lung function testing, ii) Continuous IAQ monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modeling for early identification and management of exacerbations. The ultimate objective is to design and evaluate an innovative integrated care service aiming at enhancing both IAQ and the management of multimorbid patients with chronic obstructive respiratory diseases, with focus on COPD and severe asthma.
- Detailed Description
The study is structured as a comprehensive two-phase approach. From January to December 2024 (Phase I) the protocol focuses on the assessment, and refinement, of the four core components of the study: i) Enhanced lung function testing, ii) IAQ home monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modelling for early detection and management of exacerbations. The main outcome at the end of Phase I is the design of an innovative integrated care service aiming at enhanced management of exacerbations and reduction of unplanned hospitalizations in high-risk patients.
From January to December 2025 (Phase II), the protocol aims to refine the novel clinical process, including the four core components alluded to above, as well as to evaluate the potential for healthcare value generation and scalability/transferability of the new integrated care service.
PHASE I (2024):
1. Enhanced Lung Function Testing: Adoption of oscillometry (forced oscillation technique) to measure respiratory system resistance and reactance, as a complementary tool of forced spirometry, exploring its potential for patients' monitoring and management of exacerbations.
2. Continuous Monitoring of IAQ at patients' homes: Assessment of advanced monitoring systems in patients' homes to continuously track air quality parameters, enabling the identification of environmental triggers linked to respiratory exacerbations.
3. Advanced Digital Support to innovative clinical processes with a two-fold aim: i) patient's empowerment for self-management of his/her condition, and ii) enhancing the role of the nurse case manager for early detection and management of exacerbations promoting share care agreements between the patient and the reference doctor (primary care physician and/or specialist). To this end, adoption of an Adaptive Case Management (ACM) Approach constitutes a key element.
4. Predictive Modeling: Development, and refinement, of machine learning-based modelling for early detection and management exacerbations. Key input data in the modelling approach will be: i) Clinical information (symptoms, Patient Reported Outcome Measures - PROMs), ii) Lung function testing, and iii) Patient's self-capturing physiological data through wrist sensors (health rate, heart rate variability and physical activity). Moreover, the impact of IAQ monitoring in the modelling will be explored.
The implementation, and refinement, of the four components alluded to above, as well as the design of the novel integrated care service, will be done with active engagement of patients, healthcare professionals, and other stakeholders in a co-design process using the Plan-Do-Study-Act (PDSA) methodology. Two PDSA cycles, with a six-month duration each, will be undertaken during 2024.
PHASE II (2025):
From January to December 2025, two additional PDSA cycles (six-month duration each) are planned to cover the following objectives:
1. Refinement of the novel integrated care service for enhanced management of exacerbations, as well as the implementation and continuous assessment of the four core components described in PHASE I.
2. Assessment of the outcomes of the novel integrated care service using the Quintuple Aim framework, that is, considering: i) Healthcare outcomes, ii) PROMs/Patient Reported Expirence Measures (PREMs), iii) healthcare professionals' engagement, iv) operational costs, and v) assessing equity. Comparison with conventional care will be done using a propensity score matching to elaborate a control group.
3. Evaluation of the process of deployment of the service using the Consolidated Framework for Implementation Research (CFIR) to identify barriers/facilitators for achieving a sustainable adoption, target candidates for the novel service, as well as potential for service transferability to other sites.
At the end of PHASE II, a mature service design ready for adoption should be available. Besides fulfilment of the objectives of K-Health in Air, the key lessons learned in the two-years period should provide novel insights for enhanced management of chronic patients with multimorbid conditions.
(Enclosed find: i) the Patient's Informed Consent approved by the Ethics Committee, as well as ii) the study protocol approved by the Ethics Committee of the Hosptial Clínic de Barcelona (HCB-2023-0126)).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- 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.
- Dementia.
- Inability to perform independent daily activities.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Follow-up 200 high-risk chronic respiratory outpatients for 2 years. EMR & registry data 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. Follow-up 200 high-risk chronic respiratory outpatients for 2 years. Physiological data - Beat One Watch 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. Follow-up 200 high-risk chronic respiratory outpatients for 2 years. Air quality monitoring at patient's home 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. Follow-up 200 high-risk chronic respiratory outpatients for 2 years. Patient Empowerment 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. Follow-up 200 high-risk chronic respiratory outpatients for 2 years. Characteristics of exacerbations 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. Follow-up 200 high-risk chronic respiratory outpatients for 2 years. Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023) 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 EMR & registry data 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.
- Primary Outcome Measures
Name Time Method Changes in use of healthcare resources - Unplanned hospital admissions 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 individualsChanges in use of healthcare resources - Emergency room visits 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 individualsChanges in use of healthcare resources - Exacerbations 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 individualsChanges in use of healthcare resources - Primary care visits. 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 Outcome Measures
Name Time Method Patient reported experience (PREMs) - Physiological wellbeing 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.Patient reported experience (PREMs) - Person-centeredness 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.Patient reported experience (PREMs) - Social Participation 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.Healthcare costs 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 individualsPatient reported experience (PREMs) - Enjoyment of life 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.Patient reported experience (PREMs) - Resilience 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.Patient reported experience (PREMs) - Physical functioning 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.Patient reported experience (PREMs) - Continuity of care 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.Patient reported outcomes (PROMs) - Dyspnea 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 COPDPatient reported outcomes (PROMs) - Asthma symptoms 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 COPDPatient reported outcomes (PROMs) - Functional problems related to asthma 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 COPDPatient reported outcomes (PROMs) - COPD symptoms 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 COPDPerformance of the digital support in terms of robustness and usability - Usability 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.Patient reported outcomes (PROMs) - Sino-Nasal symptoms 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 COPDPatient reported outcomes (PROMs) - Adherence to inhalers 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 COPDPerformance of Predictive Modeling for Enhanced Management of Exacerbations During 2025 Model accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve
Equity of the intervention 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 individualsPerformance of the digital support in terms of robustness and usability - Customer Satisfaction 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.
Trial Locations
- Locations (1)
Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
🇪🇸Barcelona, Spain