K-HEALTH in AIR - Barcelona Pilot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-13

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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)).

Conditions

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Severe Asthma COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Air quality monitoring at patient's home

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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)

Intervention Type DEVICE

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

Physiological data - Beat One Watch

Intervention Type DEVICE

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

Patient Empowerment

Intervention Type DEVICE

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

Characteristics of exacerbations

Intervention Type OTHER

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

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.

EMR & registry data

Intervention Type 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).

Interventions

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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

Intervention Type OTHER

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).

Intervention Type OTHER

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.

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type OTHER

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

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

Intervention Type DEVICE

Physiological data - Beat One Watch

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

Intervention Type DEVICE

Patient Empowerment

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

Intervention Type DEVICE

Characteristics of exacerbations

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

Intervention Type OTHER

Eligibility Criteria

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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.