K-HEALTH in AIR - Barcelona Pilot - Cohort

Enrolling by invitationOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

October 13, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

August 31, 2026

Conditions
Severe AsthmaCOPD
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.

Trial Locations (1)

08036

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

All Listed Sponsors
collaborator

Hospital Clinic of Barcelona

OTHER

lead

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER