K-HEALTH in AIR - Barcelona Pilot - Cohort

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.

Conditions

• Severe Asthma
• COPD

Interventions

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

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).

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.

DEVICE

Physiological data - Beat One Watch

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

DEVICE

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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  collaborator OTHER

• Institut d'Investigacions Biomèdiques August Pi i Sunyer

  lead OTHER

Principal Investigators

• JOSEP ROCA TORRENT, MD, PHD · Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)

Eligibility

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-13

Primary Completion

2025-12-31

Completion

2026-08-31

Countries

• Spain

Study Locations