Knowledge for Improving Indoor Air Quality and Health: Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months.
Conditions: Severe Asthma, COPD
Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
1 
K-HEALTHinAIR (KHiA) 
Knowledge for improving indoor air quality and health 
 
Principal investigator: 
Surname: Roca Torrent  
              
Name: Josep (MD, PhD) 
Professional category: Senior consultant at HCB and IDIBAPS Researcher 
 
Associated researchers at IDIBAPS: 
Surnames: González Colom 
 
 
Name: Rubèn (BsC, MsC) 
Professional category: Data Scientist, Pre-doctoral researcher at IDIBAPS 
Surnames: Cano Franco  
 
 
Name: Isaac (BsC, MsC, PhD) 
Professional category: Post-doctoral researcher at IDIBAPS, Associate professor at the University 
of Barcelona 
Surnames: Burgos Rincón  
 
 
 
Name: Felip (PhD) 
Professional category: Emeritus Researcher at IDIBAPS 
Surnames: Gómez López 
 
 
Name: Alba (Nurse, MsC) 
Professional category: Predoctoral researcher at IDIBAPS 
 
Surnames: Hernandez Carcereny 
 
 
Name: Carme (Nurse, PhD) 
Professional category: Nurse Directorate – Coordination of Innovation  
 
Associated researchers at CatSalut: 
Surnames: Vela  
 
 
 
Name: Emili (BsC, MsC) 
Professional category: Data Scientist, coordinator of the Catalan Health Surveillance System 
(CHSS).  
Catalan Health System (CatSalut). Digitalization for the Sustainability of the Healthcare (DS3)  
Surnames: Piera-Jimenez  
 
 
 
Name: Jordi (PhD) 
Professional category: Coordinador of the Catalan Digital Health Strategy. Catalan Health System 
(CatSalut). Digitalization for the Sustainability of the Healthcare (DS3) 
 
 
 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
2 
Associated researchers at CAPSBE: 
Surnames: Herranz 
 
 
 
Name: M Carmen (Nurse, CAPSBE) 
Professional category: Nurse, Referent de Benestar emocional i Comunitari (RBEC) i 
Coordinadora de recerca d'infermeria. CAP Casanova. Pre-doctoral researcher at IDIBAPS 
 
Surnames: Sisó Almirall   
 
 
Name: Antoni (MD, PhD) 
Professional category: Primary Care Physician. Research Coordinador at CAPSBE. President of the 
Catalan Society of Primary Care.  
 
Associated researchers at Institut Catalan of Health (ICS) – Primary Care: 
Surnames: Sorribes  
 
 
 
Name: Marta, MD  
Professional category: Primary Care Physician. Medical Director at Numancia (ICS) 
 
 
Associated Groups at Campus Clinic: 
-Bioengineering and Infrastructures Dpt.: Ferran Rodriguez, Manel Sanz, Felipe Lopez, Gerard Trias 
-ICR- Pneumology Service: Dr O Sibila, Dra E Arismendi 
-ICMiD: Infectious Diseases (Dr JA Martinez), AVI (Dr P Castro) & MDI 11.1 (Dr A Lopez-Soto) 
-Home Hospitalization: Dr J Altes & Dr D Nicolas  
-Clinical Informatics: Dr X. Borrat 
  
Promoter:  
Hospital Clínic - IDIBAPS:  Project K-Health in Air (https://k-healthinair.eu/)  
(Call: HORIZON-HLTH-2021-ENVHLTH-02 - RIA – Proposal number: 101057693) 
Surname: Roca Torrent  
              
Name: Josep (MD, PhD) 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
3 
PROTOCOL 1 – FOLLOW-UP OF 200 PATIENTS DURING 
THE PROJECT LIFETIME 
 
1.1 RATIONALE 
 
Chronic obstructive pulmonary disease (COPD) is one of the major disorders included in the WHO 
program addressing non-communicable diseases. It is currently the third leading cause of death. 
Despite COPD prevalence is not expected to increase in developed countries, projections for the 
next decade indicate an escalating burden of this condition on both health and social support 
systems, mainly due to population ageing.  
 
Prevention of acute episodes (exacerbations) in patients with COPD1, as well as enhanced 
management of comorbidities2, are the two major actionable factors to reduce the societal burden 
of the disorder. 
 
The 2023 GOLD guidelines1 for COPD management states that “exacerbations are mainly triggered 
by respiratory viral infections although bacterial infections and environmental factors such as 
ambient air pollution and temperature changes may also initiate, or amplify, these events”.  
 
The current protocol has been primarily designed to assess the impact of altered indoor air quality 
(IAQ) on acute events (exacerbations) in patients with COPD showing comorbidities assessed by 
Adjusted Morbidity Groups (GMA)3,4 scoring.  
 
The follow-up of a cohort of 200 vulnerable patients over a period of three years offers a unique 
opportunity to explore the potential of digitally supported integrated care services for enhanced 
management of chronic patients. To this end, the current observational study protocol aims to 
assess the impact on patients’ empowerment for self-management, as well as potential healthcare 
efficiencies generated by a nurse case manager supporting the relationships between patients and 
their primary care physicians.  
 
The study design also allows to capture a variety of patients’ self-reported data that, in turn, should 
facilitate detection of subclinical events eventually related with impaired IAQ. Consequently, there 
are clear synergies between the two goals addressed in the protocol.    
 
1.2 OBJECTIVES 
 
❖ Project objectives:  
➢ Analyse the relationships between patient’s home IAQ and health status with focus on 
acute health effects.  
 
❖ Local research group objectives:  
➢ To assess the potential of digitally enabled integrated care for community-based 
preventive management of exacerbations.  

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
4 
➢ To explore enhanced assessment of lung function at community level by combining 
measurements of forced oscillation technique (FOT) and forced spirometry (FS).  
 
❖ The results of this study will be also used to:  
➢ Provide the information needed to design in vivo or in vitro studies facilitating the 
identification of sources, health impact, and mechanisms of action that ultimately should 
enable the generation of recommendations for the prevention of undesirable health 
effects of impaired IAQ (PHASE II, > M18). 
 
1.3 METHODS  
 
1.3.1 Study Population (n=200) 
 
The pilot will be entirely developed in the Integrated Healthcare District of Barcelona-Esquerra 
(AISBE) (surface of 74,668 m2 and with 520 k citizens).  
 
From AISBE, 200 multimorbid outpatients with chronic obstructive pulmonary disorders (COPD, 
bronchiectasis, and severe asthma refractory to therapy) will be recruited for the study. The 
study will be focused on moderate to high-risk outpatients identified through the AMG score, 
among them, the patients with cardiovascular disorders and type II diabetes mellitus will be 
prioritized. 
As described in detail below (1.3.1.1), a first candidate screening will be made through the Catalan 
Health Surveillance System5 (CHSS), identifying all the potential candidates that meet the 
conditions exposed above.  
 
As part of the RAE consulting sessions, the research protocol will be explained to primary care 
professionals and the role of the nurse attached to the project, who will join the primary care team 
(CAPSBE and Numància) as case manager nurse. This nurse will contact, on behalf of the primary 
care team, the candidates and inform them about the study within a rutinary follow up visit  If the 
candidate manifests the willingness to participate, the study nurse to provide him sufficient 
information to judge whether or not participating in the study, as well as clarifying any question 
that may arise Before being enrolled in the study the participants must sign an informed consent. 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
5 
1.3.1.1 The elaboration of the study dataset & the patients’ enrolment procedure   
 
Preparation of the study cohort  
Due to the uniqueness of the process adopted in the current study protocol, the generation of a 
pre-study database is deemed necessary to perform a detailed screening of potential participants.  
The rationale of the process for generation of the pre-study dataset relies on three considerations 
indicated below. The approach will be constrained to the development of the Barcelona pilot of 
the K-Health in Air project.   
a) Safe access to the CHSS dataset owned by CatSalut - Since January 2021, key personnel of 
the research team (IDIBAPS and CatSalut-DS3) has been collaborating with the OECD 
Action 
to 
Support 
JADECARE 
(https://www.jadecare.eu/) 
under 
HaDEA 
(https://hadea.ec.europa.eu/) supervision. The IP of the current research is the 
coordinator of the Catalan original Good Practice in JADECARE. This ongoing collaboration 
allows a safe extraction of a dataset of approximately 40 thousand including all patients 
with chronic obstructive disorders living in the AISBE district. Data on diagnoses, GMA 
scoring and use of health and social care resources are available. High-quality standards 
for data management ensuring patients’ privacy have been well established.  Data 
management will be conducted by Rubén Gonzalez Colom (RGC, IDIBAPS) in collaboration 
with Emili Vela (EV, CatSalut-DS3). 
b) Secure merging of the CHSS dataset with the corresponding Electronic Health Records at 
Hospital Clinic - The main purpose is to validate the diagnosis of chronic obstructive 
pulmonary disease and assess disease severity. Accordingly, the two main inclusion criteria 
(Section 1.3.1.2), GMA scoring and severity of respiratory condition, will be properly 
evaluated. Such merging will be done, within the Hospital Clinic premises, by RGC in 
collaboration with the Clinical Informatics team (Dr X. Borrat) keeping identical standards 
of quality for data management.  
c) High quality and potential of the final dataset. The elaboration of the list of potential 
candidates for the study, as described, is limiting potential selection bias to the following 
two factors: i) willingness to participate, and ii) level of digital literacy. We believe that the 
approach can facilitate generalization of the results of the clinical management protocol. 
Moreover, it offers clear logistics advantages for the recruitment of candidates while 
following good practice for clinical research.  
The database created through this process will strictly serve the intended purpose and will not 
be utilized for any other purposes or studies. 
Enrolment of candidates  
Step 1 - Engagement of primary care professionals - The elaboration of the dataset of potential 
candidates will allow the identification of the corresponding primary care physicians.  The study 
protocol will be initially constrained, within AISBE, to the primary care units pertaining to CAPSBE 
and Numancia. Several sessions, aiming at engaging the primary care physicians into the study, are 
planned.  Full information on the IAQ protocol will be provided and share care agreements 
between primary care and specialists (Dr Josep Roca, with the support of the home hospitalization 
team and the pneumology service) will be proposed. The nurse case manager (Alba Gomez) will 
have two main roles in the study: i) collection of information for the IAQ study protocol, and ii) 
ensure care continuum. Main actions of the nurse case manager will be: i) promotion of patient’s 
empowerment for self-management/early detection of exacerbations, and ii) bridging between 
primary care teams and specialized care.   

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
6 
Step 2 -   Initial contact with potential candidates – An initial phone visit of the nurse case manager 
on behalf of the primary care team will be used to: i) introduce the project, ii) do a short screening 
of the potential candidate assessing inclusion/exclusion criteria, and, if the patient agrees, iii) set 
the first face-to-face visit at patient’s home.  
Step 3 – Recruitment and characterization of the candidates - We plan three, face to face visits of 
the nurse case manager at the patients’ home to complete the process of recruitment and 
characterization of each patient.  
Visit 1 - Detailed information on the study protocol and signature of the consent form 
(estimated 30-45 min)  
Visit 2 - Clinical assessment and agreement on the clinical support plan, to be shared with 
the primary care physician, and patient’s education for self-management mimicking the 
protocol recently reported in 6. Instructions for use of the chat and sensors (home-based 
IAQ sensor and wrist sensor) (estimated 60-90 min) 
Visit 3 – Administration of the K-Health in Air questionnaires for baseline 
characterization and pulmonary capacity assessment through FS and FOT measurements 
(estimated 45 minutes). 
At the end of visit 3, the patient will be fully recruited and characterized. The follow-up plan will 
be guided by the IAQ study protocol described below, but the clinical management of the patients 
will be personalized according to the individual share care plan agreed with the patient and their 
primary care physician. The communication channel (chat) managed by the nurse case manager 
will have a central role in the decision-making process. A close follow-up of the evolution of the 
clinical setting with be done with the supporting role of the PI (Dr Josep Roca). The information 
provided by the wrist sensor will not be used to take clinical decisions by the nurse case manager.  
The use of the data provided by the wrist sensor is described in detail below.    
1.3.1.2 Inclusion criteria 
 
✓ Patients must be allocated in the moderate, high, and very high-risk tiers of the population-
based risk pyramid deducted from the AMG score distribution of the entire region of Catalonia. 
✓ Patients must have at least a chronic obstructive pulmonary disease (COPD, bronchiectasis, or 
severe asthma). Clustering of COPD, cardiovascular disorders and diabetes type II will be 
prioritized. 
✓ Patients must be able to participate throughout the entire study period (3 years). 
✓ Patients must be autonomous for their daily life activities. 
✓ Patients must sign the informed consent for secondary use of the data collected. 
✓ The patients must have the commitment to wear a wrist sensor during the entire study period. 
✓ The patients must live in AISBE health district. 
 
1.3.1.3 Exclusion criteria 
 
× 
Patients with dementia and/or unable for follow-up purposes/unable for independent daily 
life activities will not be considered for the study. 
× 
Patients with Wi-Fi internet connection available at home will be prioritized, but it will not be 
an exclusion criterion, in these cases the connection might be granted through GSM-SIM. 
× 
Patients with a smartphone and acceptable skills for digital tools management will be 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
7 
prioritized, but it will not be an exclusion criterion. To guarantee the inclusivity of the protocol, 
the study also considers the participation of patients who might have limitations in using digital 
technologies. In this regard, three participation modes based on the patients’ digital skills and 
resources are proposed: 
 
Basic participation (Minimum requirement to participate in the study): implies the collection of 
fundamental data along with a subsequent telephonic follow-up for patient management. 
Intermediate participation: In addition to the basic modality, this level involves the use of a wrist 
sensor to monitor physical activity, heart rate and derived variables (Requires a smartphone - 
Passive data collection). 
Complete participation: In addition to the intermediate modality, this level considers using a 
digital application (App) for the patient’s follow-up and management (Requires a smartphone and 
digital literacy). 
 
Detailed information on the implications for the study can be found in the section 1.3.3.4 "Modes 
of participation." This section elucidates the specific data collection methods employed within 
each participation mode. 
 
 
1.3.2 Study period 
 
July 2023 – March 2026. The recruitment of participants will be initiated on early July 2023 and 
completed within two-months. The follow-up will last until March 2026, and a first assessment of 
the results will be done at M18 (February 2024).  
 
1.3.3 Variables 
 
The information collected to explore the relationship between the IAQ and health status is 
structured in two domains, that is: IAQ information (1.3.3.1) and health-related data (1.3.3.2).  
 
Regarding IAQ information, the study will make use of intelligent sensors installed at patients' 
homes (MICA-INBIOT sensors) to continuously and automatically monitor IAQ.  
 
Regarding health-related data, different sources of information are considered: i) Standardized 
questionnaires covering several dimensions administered periodically, ii) patients’ self-tracked 
information (incidences, chat with the nurse case manager, short questionnaires using Likert 
scales, etc…) collected through an App (Health Circuit-KHiA) (see General Project Description); iii) 
Biological (Heart rate, pulse oximetry, body temperature) & physical activity information collected 
through a wrist sensor (One Beat); iv) Clinical records, including lung function measurements), and 
v) Registry data obtained from the Catalan Health Surveillance System (CHSS).    
 
All data collected in the study will be gathered using a study ID. For the subsequent analyses, the 
data will be totally anonymized to the investigators after removing all direct and indirect 
identifiers. Data transfer will follow two well-differentiated paths. It will be either directly 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
8 
transferred to INBIOT premises (automatic and continuous acquisition of IAQ) or administered 
through a dedicated REDCap project at https://redcap.clinic.cat.  
 
Two key roles have been identified for the management of the study protocol: 
 
1. Project manager taking care of all non-health related logistics, as well as scientific aspects of 
the project. Such role will be covered by Ruben Gonzalez-Colom 
2. Nurse case manager with the following roles: i) collection of health data; ii) supporting 
patients; and iii) coordinating the interactions between patients and health professionals, 
fundamentally the primary care team.  
 
1.3.3.1 Air Quality measurements 
 
All the Air Quality measurements will be preceded by an environmental characterization 
addressing different aspects such as the living surface in m2, the number of dwellers, the number 
of ventilation points, the use of fireplaces, the presence of moulds, etc. The environmental 
characterization will be performed at study entry and updated along the pilot if needed. 
 
A) IAQ continuous monitoring will be performed using the MICA-INBIOT smart device. One 
desktop MICA-INBIOT device will be installed at each patient home. Connectivity will be 
ensured via Wi-Fi.  
 
Detailed information on the specs of MICA device and its integrated sensors is available in the 
Annex 1 and the manufacturer’s webpage (https://www.inbiot.es/soluciones/dispositivos-
mica/mica).  
TABLE 1 – Continuously monitored IAQ features with MICA device. 
Feature 
Units 
Indoor temperature 
ºC 
Relative humidity  
HR % 
Formaldehyde 
µg/m3 
Total VOCs 
ppb 
PM 1/2.5/4/10 
µg/m3 
CO2 
ppm 
 
B) OAQ (Outdoor Air Quality) continuous monitoring of the district will be imported to REDCAP 
from the Open Data Portal of Catalonia and/or the Aeris Weather platform. 
 
TABLE 2 – Continuously monitored OAQ features. 
Feature 
Units 
NO 
µg/m3 
NO2 
µg/m3 
NOX 
µg/m3 
SO2 
µg/m3 
O3 
µg/m3 
CO 
µg/m3 
PM 10 
µg/m3 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
9 
 
1.3.3.2 Patients’ health status and use of healthcare resources  
 
 The clinical information of the patients enrolled in the study will be obtained from different 
sources: 
 
C) Electronic Health Records, from the Hospital Clinic of Barcelona (SAP) and primary care (eCAP) 
will be used as a source of information on clinical episodes and procedures.  
 
TABLE 3 – Health information retrieved from hospital and primary care health records. 
Feature 
Units 
Disease diagnosis 
ICD10 
Clinical procedures 
ICD10 
Hospital admissions - Length of stay 
date - days 
ICU length of stay (if applicable) 
days 
Lab tests 
miscellaneous 
Visits (outpatients, ER, day hospital, etc…) 
Episode date, type 
Frailty (functional, social, etc...) 
Standardized records 
 
D) Standardized questionnaires will be utilized to assess general and mental health, quality of life 
and patient’s experience. The questionnaires will be dispensed at study entry and periodically 
administered throughout the study period (for detailed information on the questionnaires see 
Annex 2). 
 
TABLE 4 – General health, mental health, quality of life and patient reported experience 
questionaries administered. 
Feature 
Units 
Periodicity 
General Health Questionnaires 
ICHOM Adult Set 
Every 6 months 
Mental Health Questionnaires 
PHQ-9 
Every 2 months 
Quality of Life Questionnaires 
EQ-5D-5L 
Every 2 months 
Patient Reported Experience 
PARIS (adapted) 
Every 6 months 
 
E) Registry data will be yearly extracted from the Catalan Health Surveillance System (CHSS), 
encompassing: 
 
TABLE 5 – Health information retrieved from health registries. 
Feature 
Units 
Disease diagnosis 
ICD10 
Medication prescribed 
ATC 
Utilization of healthcare resources 
Number of encounters with healthcare professionals at 
different levels; primary care visits, outpatient care visits, 
mental health ambulatory visits, emergency room visits, 
day hospital visits, intermediate care admissions, hospital 
admissions, admissions in mental health centers. 
Total healthcare expenditure 
€ 
 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
10 
F) Assessment of pulmonary capacity through FOT and FS measurements that will be performed 
at entry into the study and every 6 months. Measurements will be done using Lothar-Medtech 
equipment (https://alds.health/). 
 
 
TABLE 6 – Features utilized to assess the pulmonary capacity. 
Feature 
Units 
Periodicity 
FS (FVC, FEV1, FEV1/FVC ratio) 
(ml, ml, %) 
Every 6 months 
FOT resistance (R5 and R5-20) 
Pressure/meter/second 
Every 6 months 
FOT reactance (X) 
Pressure/volume 
Every 6 months 
Resonance frequency 
Hz 
Every 6 months 
 
G) Patients’ self-tracked information. Recording of steps walked and heart rate will be 
continuously monitored by the Beat One watch (https://beat-one.com/producto/la-salud-en-
tu-mano/). Heart rate variability, stress level and sleep structure will be calculated from 
continuous monitoring of heart rate. Pulse oximetry, arterial pressure and body temperature 
can be measured by Beat One, on demand by the nurse case manager. Moreover, record of 
incidences will be extracted from the chat messaging with the nurse case manager, through 
the patients’ App). Additionally, assessment of patients’ will be obtained from short 
questionnaires (Likert scale) supported by the App. 
  
Measurements provided by Beat One will not be used for clinical purposes. Clinical decision 
making by the nurse case manager (and supporting physicians) will be patient-nurse interactions 
wherein the chat and phone, will be core elements. If a face-to-face visit is required, conventional 
measurements (lung function, arterial pressure, heart rate) could be done by the nurse case 
manager, as needed.  
 
The information obtained through the Beat One watch will be used as follows: 
 
The initial purpose of the measurements generated by Beat One is to use them to explore patterns 
that might contribute to identify early exacerbations and/or reflect the health status of the patient 
7,8. Such measurements will only have a research purpose within the first 12 months of the follow-
up.  
 
If the initial research data suggest potential value of such continuous measurements, we will plan 
specific validation protocols using equipment registered as medical devices.  To this end, different 
commercial companies are being considered. Such future validation protocols will be submitted to 
the CEIC for approval on due time, likely after month eighteen of the follow-up.  
A final step to be achieved within the project lifetime, if the results of the validation studies are 
endorsing our hypothesis on the potential predictive role of heart rate variability, will be to submit 
the entire digital solution (App + selected sensors) to the corresponding accreditation agencies for 
future use for clinical decision-making, following the steps indicated in our recent work reported 
by Baltaxe E et al. The Assessment of Medical Device Software Supporting Health Care Services for 
Chronic Patients in a Tertiary Hospital: Overarching Study. J Med Internet Res 2023;25e40976 
https//www.jmir.org/2023/1/e40976. 2023;25(1): e40976. doi:10.2196/40976. Final submission 
to the AEMPS for approval will be considered upon results.   

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
11 
1.3.3.3 Data collection calendar (1st year) 
 
Table 7 summarizes the characteristics and schedule of the measurements. 
 
TABLE 7 – Data collection calendar. 
 
Operation 
Entry 
M1 
M2 
M3 
M4 
M5 
M6 
M7 
M8 
M9 
M10 
M11 
M12 
Air Quality Measurements 
A 
IAQ 
– 
Continuous 
monitoring 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
B 
OAQ 
- 
Continuous 
monitoring 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
Patients’ health status and utilization of healthcare resources 
C 
Health follow-up 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
D 
Health, mental 
health, quality of life 
and patient 
experience 
questionnaires 
X 
- 
RS 
- 
RS 
- 
X 
- 
RS 
- 
RS 
- 
X 
E 
Utilization of 
healthcare resources 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
X 
F 
Pulmonary capacity 
assessed with forced 
oscillatory technique 
and forced 
spirometry 
X 
- 
- 
- 
- 
- 
X 
- 
- 
- 
- 
- 
X 
G 
Patients’ self-tracked 
information 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM 
CM stands for continuous monitoring and RS for reduced set of questionnaires.  
 
1.3.3.4 Modes of participation 
 
1.3.3.4.1 Basic Participation 
 
Participation in the basic mode allows the study of the relationship between the air quality in 
patients’ home and health. The participation under the basic regime involves: 
* Continuous home IAQ monitoring using a smart device (MICA) and OAQ monitoring exported 
from Aeris weather. 
* Access to patients’ medical history and health registry data from the Catalan health system. 
* Periodic assessment of the lung capacity using forced spirometry and forced oscillation 
techniques.  
* Periodic administration of health questionnaires. 
* Telephonic follow-up 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
12 
1.3.3.4.2 Intermediate Participation 
 
Participation in the intermediate mode, in addition to the commitments and benefits of the basic 
mode, allows the study of biomarker identification for early detection and appropriate prevention 
of pulmonary disease exacerbations. In addition to the data collected in the basic mode, this mode 
involves: 
* Continuous monitoring of daily physical activity and heart rate using a smart bracelet (Beat One).  
 
1.3.3.4.3 Complete Participation 
 
Participation in the complete mode, in addition to the commitments and benefits of the 
intermediate mode, enables integrated management of patients’ disease through a digital 
application installed on patients’ smart phone, allowing detailed monitoring and more direct and 
continuous interaction with healthcare personnel. In addition to the data collected in the 
intermediate mode, this mode involves: 
* Installation of the Health Circuit app on patients’ smart phone as a means of communication with 
the case manager nurse and managing future appointments. 
* Periodic administration of health questionnaires through the Health Circuit app. 
 
As a summary,  
1- The patients participating in all three categories (basic, intermediate, and complete) will 
be included in the analysis of the core question of the project; that is, assessment of the 
relationships between IAQ and health.  
2- The patients participating in the intermediate and complete categories will be included in 
the elaboration/evaluation of predictive modelling for identification of exacerbations and 
early preventive interventions through the corresponding primary care physician. 
3- The patients participating in the third option (complete) will be candidates for evaluation 
of the Health Circuit App as a tool for data capture and enhanced community-based 
management of multimorbidity aiming at preventing unplanned hospitalizations.  
 
1.4 ETHICAL ASPECTS 
 
The study protocols will be conducted in compliance with the Helsinki Declaration (Stronghold 
Version, Brazil, October 2013) and in accordance with the protocol and the relevant legal 
requirements (Biomedical Research Act 14/2007 of 3 July).  
 
All participants in the study must sign an informed consent ahead of any procedure. The 
participants can withdraw their consent at any time without altering the relationship with their 
doctor or causing any harm to their treatment. 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
13 
1.4.1 Data management  
 
At study entry, a unique study ID will be assigned to all the participants. Subsequently, all the data 
collected during the study will be referred by the patient’s study ID and totally anonymized 
removing all direct and indirect identifiers, guaranteeing the confidentiality of the patient’s 
personal information.  
Once anonymized, the data will be transferred to a central repository coordinated by the 
consortium partners ATOS and IIIA-CSIC and gathered through the study ID. These partners will be 
also in charge to determine the protocols for explorative data analytics and feature engineering 
techniques that will be applied to extract features and to discover correlations from the collected 
information. 
The data collected within the study will be transferred to the central repository following two 
independent paths: 
The IAQ parameters captured by the MICA devices will be recorded into My inBiot, the 
manufacturer’s IoT data platform, and directly transferred to the central repository. 
All other study data, collected by the Hospital Clínic / IDIBAPS research team, will be managed and 
gathered through a dedicated RedCap project at https://redcap.clinic.cat. The data will be 
periodically sent to the central repository. 
 
1.4.1.1 My inBiot - Data management 
 
At study entry, a desktop MICA IAQ monitor will be installed at patient’s home by the nurse case 
manager. All the devices will be set up and managed by a single user (khelathinair@gmail.com) 
controlled by the nurse case manager and the project manager, thus avoiding the need of 
creating a user linked to a patient email account or providing any type of personal or contact 
information to the manufacturer.  
During the installation the MICA serial number will be associated to the patient study ID, allowing 
gathering the data while preserving the anonymization. 
The MICA devices will transfer the IAQ monitoring data to My inBiot platform, an AWS cloud 
infrastructure that provides full control and security of information using TLS1.2 encrypted 
communications between the client application and devices, as well as encryption at rest of the 
data in the databases through symmetric KMS keys. 
In case of device dysfunction or breakdown, it will be replaced by the nurse case manager.  
If abnormal indoor measurements indicating poor IAQ were detected at the patient’s home, the 
information will be communicated to the patient/carers, as well as to the primary care physician. 
Informed offline decisions will be shared (and agreed) among all actors to introduce the 
corrections needed.  
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
14 
1.4.1.2 Health Circuit - Data management 
 
K-HEALTHinAIR study protocols in Barcelona consider the use of a digital health tool for the follow-
up of study participants.  
The digital health tool will be provided by the spin-off Health Circuit SL (www.healthcircuit.es), 
with a prototype-level digital health platform hosted in a private cloud in European servers that  
will be released in April 2023 for the inclusion of the first study participants.  
Study participants will be registered in the Health Circuit platform by the nurse case manager at 
study entry using a project email account (khelathinair@gmail.com). The patient’s study ID will be 
set as username, and the password will be defined by the patient at this moment. Patient 
identifiers, either direct or indirect, will not be used to define the patient user, nor will they be 
collected at any time through the Health Circuit application. 
Figure 1 depicts the data management flow chart of the Health Circuit application. After the 
inclusion of a study participant, the research protocol will dictate the release of monitoring tasks 
to study participants. Monitoring tasks will include regular follow-up questionnaires, 
PROMs/PREMs using Likert scales and monitoring of daily physical activity (steps and minutes of 
moderate/vigorous physical activity), stress, heart rate variability (HRV) and sleep patterns that 
will be monitored by the Beat One watch. In addition, study participants will be able to 
communicate with the nurse case manager with an off-line chat. The communication channel is 
expected to be key in keeping the study participant adherent to the research protocol. The data 
collected through Health Circuit will be periodically imported by the nurse case manager to a 
dedicated REDCap project at https://redcap.clinic.cat.  
 
Figure 1: Data acquisition flow diagram of the Health Circuit application. 
 
From the Health Circuit App in the smartphone of the study participant to the Health Circuit servers 
hosting the research protocol, the following information will be exchanged. The exchange of data 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
15 
with the APP is always carried out using only the patient study ID). The data will not be shared with 
any other entity unless there is a legal obligation of a competent body. 
The APP data is stored in three independent databases: 
• Authentication data (username and password). A token persists on the participant's 
device to identify the active session. This token is deleted when the participant uninstalls 
the App.  
• Monitoring data: answers to follow-up questionnaires, PROMs/PREMs, and monitoring of 
daily physical activity (steps and minutes of moderate/vigorous physical activity), stress, 
HRV and sleep. They are stored encrypted.  
 
The data monitored by the Beat One sensor, will be directly exported to the Health Circuit 
“monitoring data” database through Bluetooth connection (SDK) and linked to the 
participant username (study ID). 
 
• Communication data: multimedia content exchanged through the off-line communication 
channel. They are stored encrypted. 
 
 
The following security measures apply to the APP and the server to ensure that study participants 
are not identified: 
• 
All communication between the APP (client) and the server is done over HTTPS to prevent 
data traffic from being spied on. 
• 
Passwords are never stored in text format on the server, but instead use Bcrypt 
(https://en.wikipedia.org/wiki/Bcrypt) to generate a "hash" code, which prevents a 
potential attacker from obtaining the user's credentials in case they gain access to the 
application database. 
• 
The data stored in each database has role access control, so a properly authenticated user 
can only access the data they have access based on their role. 
• 
The application will be published by means of Git to ensure complete traceability and 
transparency. 
 
1.4.2 Data processing and archive of records 
 
The data collected in the Health Circuit App for the research protocols will be identified only by 
the patients’ study IDs, so no information will be included to identify the participants. This will also 
apply to the continuous IAQ monitoring provided by the device MICA from manufacturer INBIOT 
(https://www.inbiot.es/soluciones/dispositivos-mica/general). Both Health Circuit App data 
stored in a dedicated REDCap project as well as the continuous IAQ monitoring data will be 
encrypted and shared to the K-HEALTHinAir project database hosted by partner ATOS Spain, which 
in no case will contain information that can directly identify the participant (such as name and 
surname, initials, address, social security number, etc.). In the event that this transfer was to occur, 
it would be for the same purpose of the study described and guaranteeing confidentiality. 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
16 
Only the study case manager and her collaborators with the right of access to the source data 
(medical history), may relate the data collected in the study with the patient's medical history. The 
identity of the participants will not be available to any other person except for a medical 
emergency or legal requirement. They may have access to the personally identified information, 
the health authorities, the Research Ethics Committee and personnel authorized by the study 
sponsor, when necessary to verify data and procedures of the study, but always maintaining 
confidentiality in accordance with current legislation. 
Statement of compliance with EU regulations 
The processing, communication and transfer of personal data of all participants shall comply with 
EU Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the 
protection of individuals with regard to the processing of personal data and the free movement of 
data, being mandatory from May 25, 2018 and Organic Law 3/2018, of December 5, Protection of 
Personal Data and guarantee of digital rights. The legal basis justifying the processing of data is the 
consent signed by the patient, in accordance with Article 9 of EU Regulation 2016/679. 
 
Only the encrypted data will be transferred to third parties and other countries, which in no case 
will contain information that can identify the participant directly (such as first and last name, 
initials, address, social security number, etc.). In the event of this assignment, it would be for the 
same purpose of the study described and guaranteeing confidentiality. 
If a transfer of encrypted data is made outside the EU, whether in entities related to the hospital 
where the patient participates, to service providers or to researchers collaborating with us, the 
participants' data will be protected by safeguards such as contracts or other mechanisms 
established by the data protection authorities. 
 
As promoters of the project, we are committed to processing the data in accordance with EU 
Regulation 2016/679 and, therefore, to keep a record of the processing activities that we carry out 
and to carry out a risk assessment of the treatments we carry out, to know what measures we will 
have to apply and how to do so. The information used will only be processed within the framework 
of this project, preserving the integrity, confidentiality and security of the information. 
 
In addition to the rights already provided for by the previous legislation (access, modification, 
opposition and cancellation of data, deletion in the new Regulation) participants can now also limit 
the processing of data collected for the project that are incorrect, request a copy or move to a 
third party (portability). To exercise these rights, they must contact the principal investigator of 
the study or the Data Protection Officer of the Hospital Clínic de Barcelona through 
protecciodades@clinic.cat. You also have the right to contact the Data Protection Agency if you 
are not satisfied. 
 
Data cannot be deleted, even if a patient leaves the study, to ensure the validity of the 
investigation and comply with legal duties and drug authorization requirements. 
 
The Investigator and the Promoter are required to retain the data collected for the study for at 
least 5 years after completion. Subsequently, personal information will only be kept by the health 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
17 
care centre and by the promoter for other scientific research purposes if the patient has given 
consent to it, and if permitted by applicable law and ethical requirements. 
 
1.5 EXPECTED OUTCOMES AND CLINICAL IMPACT 
 
- 
Study of the relationships between patient’s home IAQ and health status with focus on acute 
health effects. 
 
The analyses will be done considering two different levels: i) Barcelona pilot, and ii) information 
obtained at consortium level (using data from different scenarios). The methodological approach 
proposed by the project EU-Stands4PM: Standards for In Silico Models for Personalized Medicine 
(https://www.eu-stands4pm.eu/) will be adopted in the current project. Briefly, EU-Stands4PM 
combines data driven analyses and knowledge-based approaches to address the target objective.   
 
The main expected outcome is the identification of IAQ-related factors with potential deleterious 
impact on health status. Subsequent studies to be planned in PHASE II (≥ M18) may help to analyse 
causality and identify thresholds for specific pollutants.   
  
- 
Identifying factors triggering exacerbations in high-risk patients with respiratory diseases.  
 
The study design, including continuous patients’ monitoring with the wrist sensor (One Beat) and 
registry of incidences using the chat, as well as continuous IAQ monitoring (MICA-INBIOT), should 
allow early identification of acute clinical episodes facilitating: i) the identification of factors 
triggering exacerbations and, specifically, the role of IAQ, and ii) early management of 
exacerbations preventing progression and subsequent need for emergency room visits and/or 
hospitalizations.  
 
- 
Assessing the potential of digitally enabled integrated care for community-based preventive 
management of exacerbations.  
 
Previous studies10,11 and recent pilot data support the hypothesis that digital support of integrated 
care services for preventive management of chronic respiratory patients with co-morbidities 
generates healthcare efficiencies by enhancing patients’ empowerment for self-management and 
reducing the use of healthcare resources, mainly emergency room visits and hospitalizations. Both 
incidences and health outcomes, after one year, will be assessed in comparison with a control 
group generated using propensity score matching techniques. 
 
- 
Exploring enhanced assessment of lung function at community level by combining 
measurements of FOT and FS.  
 
FS is the gold standard test for characterization of patients with COPD and for monitoring the 
evolution of the pulmonary disease. However, performance of the test at community level can 
show quality issues disturbing interpretation. Moreover, the test may not be well tolerated by 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
18 
advanced patients. FOT testing may provide useful information for monitoring of chronic 
respiratory patients. The test does not require patients’ collaboration and is well accepted by all 
patients. 
 
We hypothesize that the two tests have complementary roles. While FS is the standard test for 
patients’ characterization, FOT would be an ideal test for patients’ monitoring (or self-monitoring).  
 
During the project we will assess concordance between the two modalities of testing and explore 
the potential benefits of introducing FOT measurements for patients’ monitoring at community 
level: primary care premises and patients’ home. Moreover, the equipment (https://alds.health/) 
will allow to explore interoperability issues between specialized and primary care that may have a 
positive impact in the design of collaborative service workflows with high potential for generating 
healthcare efficiencies.   
 
 
 
1.6 REFERENCES 
 
1.  
GLOBAL INITIATIVE FOR CHRONIC OBSTRUCTIVE LUNG DISEASE. Global Strategy for the Diagnosis, 
Management, and Prevention of Chronic Obstructive Pulmonary Disease (2023 GOLD 
Report).; 2023. 
2.  
VELA E ET AL. Population-based analysis of patients with COPD in Catalonia: a cohort study 
with implications for clinical management. BMJ Open. 2018;8(3):e017283. 
doi:10.1136/BMJOPEN-2017-017283 
3.  
MONTERDE D ET AL. Adjusted morbidity groups: A new multiple morbidity measurement of 
use in Primary Care. Aten primaria. 2016;48(10):674-682. 
doi:10.1016/J.APRIM.2016.06.003 
4.  
MONTERDE D ET AL. Multimorbidity as a predictor of health service utilization in primary 
care: a registry-based study of the Catalan population. BMC Fam Pract 2020 211. 
2020;21(1):1-9. doi:10.1186/S12875-020-01104-1 
5.  
FARRÉ N ET AL. Medical resource use and expenditure in patients with chronic heart failure: 
a population-based analysis of 88 195 patients. Eur J Heart Fail. 2016;18(9):1132-1140. 
doi:10.1002/ejhf.549 
6.  
HERRANZ C ET AL. Health Circuit: a practice-proven adaptive case management approach for 
innovative healthcare services. J Med Internet Res. Published online 2023. 
7.  
TSENG CY ET AL. Changes of heart rate variability predicting patients with acute 
exacerbation of chronic obstructive pulmonary disease requiring hospitalization after 
Emergency Department treatment. J Chinese Med Assoc. 2018;81(1):47-52. 
doi:10.1016/J.JCMA.2017.10.003 
8.  
SAIPHOKLANG -C ; ET AL. Use of a Wearable Biosensor to Study Heart Rate Variability in 
Chronic Obstructive Pulmonary Disease and Its Relationship to Disease Severity. Sensors 
2022, Vol 22, Page 2264. 2022;22(6):2264. doi:10.3390/S22062264 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
19 
9.  
BALTAXE E ET AL. The Assessment of Medical Device Software Supporting Health Care 
Services for Chronic Patients in a Tertiary Hospital: Overarching Study. J Med Internet Res 
2023;25e40976 https//www.jmir.org/2023/1/e40976. 2023;25(1):e40976. 
doi:10.2196/40976 
10.  
CASAS A ET AL. Integrated care prevents hospitalisations for exacerbations in COPD 
patients. Eur Respir J. 2006;28(1):123-130. doi:10.1183/09031936.06.00063205 
11.  
HERNÁNDEZ C ET AL. Effectiveness of community-based integrated care in frail COPD 
patients: a randomised controlled trial. Prim Care Respir Med. Published online 2015:25. 
doi:10.1038/npjpcrm.2015.22 
 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
20 
ANNEX 1 – IAQ MONITORING DEVICE 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
21 
ANNEX 2- HEALTH QUESTIONNAIRES 
PART A. SOCIO-DEMOGRAPHIC DATA 
 
Patient ID:_____________ 
 
1. In what year were you born?  __/__/__  
 
2. Please indicate your sex at birth: 
1= Male 
2= Female 
3= Other 
 
3. Please indicate your highest level of schooling: 
0= None 
1= Early. Childhood education 
2= Primary education 
3= Lower Secondary education 
4= Upper Secondary education 
5= Short cycle Tertiary education 
6= Bachelor’s or equivalent level 
7= Master’s or equivalent level 
8= Doctoral or equivalent level 
 
4. Please indicate your current relationship status: 
0= Not married/partnered 
1= Married/partnered 
2= Divorced/separated 
3= Widowed 
4= Unknown 
 
5. What is your work status? 
0= Unemployed 
1= Part-time employment 
2= Full-time employment 
3= Retired 
4= Unpaid work (student, caregiver, 
homemaker, volunteer, etc.) 
 
6. Living arrangements: 
0=Lives alone 
1=Lives with others 
2=Lives in supported home (i.e. assisted living, congregate care, skilled nursing home, etc.) 
3=Homeless 
 
 
PART B. THE ICHOM DATA SET FOR ADULT POPULATION 
 
CLINICAL FACTORS 
1. Have you ever been told by a doctor that you have any of the following?  
0= I have no other diseases 
1= Heart disease (angina, heart attack, heart failure) 
2= High Blood Pressure 
3= Lung Disease (asthma, chronic bronchitis, emphysema) 
4= Diabetes 
5= Stomach disease or ulcer 
6= Kidney disease 
7= Liver disease 
8= Blood disease or anemia 
9= Cancer 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
22 
10= Depression 
11= Osteoarthritis 
12= Back pain 
13= Rheumatoid Arthritis 
14= Other medical problems: __________________ 
 
If some of the other previous questions is YES: 
Do you receive treatment for (the related diseases answered yes)? 
0=No 
 
1=Yes 
Does your (the related diseases answered yes) limit your activities? 
0=No 
 
1=Yes 
 
2. Systolic Blood Pressure: ______mmHG 
 
3. Diastolic Blood Pressure:______mmHG 
 
4. Body mass index (kg/m2) : _____ (or ask for height and weight) 
 
5. What is the patient’s total cholesterol? _____ 
 
6. What is the patient’s HDL cholesterol? _____ 
 
7. What is the patient’s diabetes status? 
 
 
0=The patient is not diagnoses with diabetes  
 
 
 
1= The patient is diagnoses with Type I diabetes 
 
 
 
2= The patient is diagnoses with Type II diabetes 
 
LIFESTYLE FACTORS 
8. 
Please indicate your smoking behavior? More detailed definitions are as follows: Daily smoker: A person who smokes 
daily. Weekly smoker: A person who smokes at least weekly but not daily. Former smoker: A person who does not smoke at 
all now but has smoke. 
0= Daily smoker 
1= Weekly smoker 
2= Former smoker 
3= Never-smoker 
4= Others 
999=unknown if ever smoked 
 
9. 
How many standard alcoholic drinks do you drink per week? One standard drink is equal to 12.5ml of pure alcohol, 
or roughly 1 small glass of wine/25cl of regular beer (5% alcohol). 
 
__________ 
 
10. Physical activity. 
a. On average, how many days per week do you engage in moderate to strenuous exercise (like a brisk 
walk, slow biking, general gardening)?_____ 
b. On average, how many minutes, per day, do you engage in exercise at this level?______ 
c. 
On average, how many minutes, per day, do you engage in exercise at this level?_____ 
d. Total minutes per week of physical activity (multiply PAVSDAY by PAVSTIME)  
0= 0 minutes 
1= 1-150 minutes 
2= >150 minutes 
SEEING 
11. At the present time, would you say your eyesight, with glasses or contact lenses if you wear them is… 
5= excellent 
4= very good 
3=good 
2= fair 
1= poor 
HEARING 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
23 
12. Would you say your hearing is 
5= excellent 
4= good 
3=a little trouble 
2= moderate hearing 
trouble 
1= a lot of trouble 
0=deaf 
 
OUTCOMES 
13. In general, would you say your health is: 
5 = Excellent 
4 = Very good 
3 = Good 
2 = Fair 
1 = Poor 
 
14. In general, would you say your quality of life is: 
5 = Excellent 
4 = Very good 
3 = Good 
2 = Fair 
1 = Poor 
 
15. In general, how would you rate your physical health? 
5 = Excellent 
4 = Very good 
3 = Good 
2 = Fair 
1 = Poor
 
16. In the past 7 days, how would you rate your fatigue on average? 
5 = None 
4 = Mild 
3 = Moderate 
2 = Severe 
1 = Very severe 
 
17. In the past 7 days, how would you rate your pain on average? 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
18. To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, 
carrying groceries, or moving a chair? 
5 = Completely 
4 = Mostly 
3 = Moderately 
2 = A little 
1 = Not al all 
 
19. In general, how would you rate your mental health, including your mood and your ability to think? 
5 = Excellent 
4 = Very good 
3 = Good 
2 = Fair 
1 = Poor 
 
20. In the past 7 days, how often have you been bothered by emotional problems such as feeling anxious, 
depressed or irritable? 
5 = Never 
4 = Rarely 
3 = Sometimes 
2 = Often 
1 = Always 
 
21. In general, how would you rate your satisfaction with your social activities and relationships? 
5 = Excellent 
4 = Very good 
3 = Good 
2 = Fair 
1 = Poor 
 
22. In general rate how well you carry out your usual social activities at home, at work and in your community, and 
responsibilities as a parent, child, spouse, employee, friend, etc.)? 
5 = Excellent 
4 = Very good 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
24 
3 = Good 
2 = Fair 
1 = Poor 
 
23.  In the past 30 days, how much difficulty did you have in standing for long periods such as 30 minutes? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 
= Extreme or cannot do 
 
24. In the past 30 days, how much difficulty was taking care of your household responsibilities? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
25. In the past 30 days, how much difficulty was learning a new task, for example, learning how to get to a new 
place? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
26. In the past 30 days, how much of a problem did you have joining in community activities (for example, 
festivities, religious or other activities) in the same way as anyone else can? 
 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
27. In the past 30 days, how much have you been emotionally affected by your health problems? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
28. In the past 30 days, how much difficulty was concentrating on doing something for ten minutes? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
29. In the past 30 days, how much difficulty was walking a long distance such as a kilometer [or equivalent]? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
30. In the past 30 days, how much difficulty was washing your whole body? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
31. In the past 30 days, how much difficulty was getting dressed? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
32. In the past 30 days, how much difficulty was dealing with people you do not know? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
25 
 
33. In the past 30 days, how much difficulty was maintaining a friendship? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
34. In the past 30 days, how much difficulty was your day-to-day work? 
0 = None 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Extreme or cannot do 
 
35. Over the past 2 weeks: 1. I have felt cheerful and in good spirits 
5= All of the time  
4= Most of the time  
3= More than half the time  
2= Less than half the time  
1= Some of the time  
0= At no time 
 
36. Over the past 2 weeks: 2. I have felt calm and relaxed 
5= All of the time  
4= Most of the time  
3= More than half the time  
2= Less than half the time  
1= Some of the time  
0= At no time 
 
37. Over the past 2 weeks: 3. I have felt active and vigorous 
5= All of the time  
4= Most of the time  
3= More than half the time  
2= Less than half the time  
1= Some of the time  
0= At no time 
 
38. Over the past 2 weeks: 4. I woke up feeling fresh and rested 
5= All of the time  
4= Most of the time  
3= More than half the time  
2= Less than half the time  
1= Some of the time 0= At no time 
 
39. Over the past 2 weeks: 5. my daily life has been filled with things that interest me 
5= All of the time  
4= Most of the time  
3= More than half the time  
2= Less than half the time  
1= Some of the time  
0= At no time 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
26 
PART C ADAPTATION OF THE PARIS SURVEY 
 
ACCESIBILITY 
1. How easy or difficult is it to get medical care in the evenings, on weekends, or holidays without 
going to the hospital? 
1= Very easy  
2= Somewhat easy  
3= Somewhat difficult  
4= Very difficult  
6 (DO NOT READ) Never needed care in the evenings, weekends, or holidays  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
2. How quickly did you get an appointment to see your doctor? 
1= Very quickly 
2= Somewhat quickly 
3= Somewhat difficult  
4= Very difficult  
6 (DO NOT READ) Never needed care in the evenings, weekends, or holidays  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
3. Was the time you waited for the appointment for your doctor? (in days) 
__________ [RANGE 0-96]  
1 (DO NOT READ) More than one doctor but doesn’t know exact number  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
4. On the actual day of the consultation, how long did you wait (for example in the doctor’s waiting 
room) before you were actually seen? (in minutes) 
__________ [RANGE 0-96]  
1 (DO NOT READ) More than one doctor but doesn’t know exact number  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
5. Was the time you waited to be seen a problem for you? 
1 =Yes  
2 =No  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
COMMUNICATION 
6. Did the doctor/nurse spend enough time with you? 
1 =Yes  
2 =No  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
7. During your communication with the health staff, how often did your doctor/nurse treat you with 
courtesy and respect? 
1 =Always  
2 =Often  
3 =Sometimes  
4 =Rarely or never  
5 =(DO NOT READ) Never tried to contact by telephone  
D (DO NOT READ) Not sure  

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
27 
R (DO NOT READ) Decline to answer 
 
8. Did this give you an opportunity to ask questions or raise concerns about recommended 
treatment? 
1 =Yes  
2 =No  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
SHARED DECISION MAKING 
9. During the past year, when you received care, has any health care professional you see for your 
[insert condition] discussed with you your main goals or priorities in caring for this condition 
1 =Yes  
2 =No  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
10. Did this involve you as much as you wanted to be in decisions about your care and treatment? 
1 =Yes  
2 =No  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
CONTINUITY AND COORDINATION 
11. Is there one doctor you usually go to for your medical care? 
1 =Yes, have a regular doctor/GP  
2 =(DO NOT READ) Yes, but have more than one regular doctor/GP  
3 =No  
4 =Yes, have nurse practitioner or physician assistant 
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
12. Not counting any time you may have been hospitalized, how many different doctors have you 
seen in the past 12 months? 
__________ [RANGE 0-96]  
1 (DO NOT READ) More than one doctor but doesn’t know exact number  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
13. Now thinking about the past 2 years, when receiving care for a medical problem, was there EVER 
a time when doctors ordered a medical test that you felt was unnecessary because the test had 
already been done? 
1 =Yes, this happened  
2 =No  
3 =(DO NOT READ) Not Applicable  
D (DO NOT READ) Not Sure  
R (DO NOT READ) Decline to Answer 
 
14. In the past 12 months, has a doctor or pharmacist reviewed with you all the medications you 
take? 
1 Yes  
2 No  
D (DO NOT READ) Not sure  
R (DO NOT READ) Decline to answer 
 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
28 
PART D. QUALITY OF LIFE (EQ-5D-5L)  
 
Under each heading, please tick the ONE box that best describes your health TODAY.  
  
MOBILITY  
I have no problems in walking about 
 
  
I have slight problems in walking about 
  
I have moderate problems in walking about   
I have severe problems in walking about 
  
I am unable to walk about  
 
  
  
SELF-CARE  
I have no problems washing or dressing myself 
 
 
I have slight problems washing or dressing myself 
 
  
I have moderate problems washing or dressing myself 
 
I have severe problems washing or dressing myself  
  
I am unable to wash or dress myself 
 
 
 
  
  
USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)  
I have no problems doing my usual activities 
  
I have slight problems doing my usual activities 
  
I have moderate problems doing my usual activities  
I have severe problems doing my usual activities 
  
I am unable to do my usual activities 
 
 
  
  
  
PAIN / DISCOMFORT  
I have no pain or discomfort 
 
  
I have slight pain or discomfort 
 
  
I have moderate pain or discomfort   
I have severe pain or discomfort 
  
I have extreme pain or discomfort   
  
ANXIETY / DEPRESSION  
I am not anxious or depressed 
 
 
 
I am slightly anxious or depressed  
  
I am moderately anxious or depressed 
 
  
I am severely anxious or depressed  
 
I am extremely anxious or depressed 
 
  

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
29 
• 
We would like to know how good or bad your health is TODAY. 
 
This scale is numbered from 0 to 100. →100 means the best health 
you can imagine / 0 means the worst health you can imagine. 
 
Please mark an X on the scale to indicate how your health is TODAY. 
 
Now, write the number you marked on the scale in the box below. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
YOUR HEALTH TODAY = 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

30/11/2023 v.10                         K-HEALTHinAIR - Knowledge for improving indoor AIR quality and HEALTH 
 
30 
PART E. MENTAL HEALTH (PHQ-9)  
 
ID:__________________  
 
DATE:________________ 
 
Over the last 2 weeks, how ofter have you been bothered by any of the following problems? 
 
 
NOT 
AT 
ALL 
SEVERAL 
DAYS 
MORE 
THAN 
HALF 
DAYS 
NEARLY 
EVERY 
DAY 
1. Little interest or pleasure in doing things. 
0 
1 
2 
3 
2. Feeling down, depressed, or hopeless. 
0 
1 
2 
3 
3. Trouble falling or staying asleep or sleeping too 
much. 
0 
1 
2 
3 
4. Feeling tired or having little energy. 
0 
1 
2 
3 
5. Poor appetite or overeating. 
0 
1 
2 
3 
6. Feeling bad about yourself-or that you are a failure 
or have let yourself or your family down. 
0 
1 
2 
3 
7. Trouble concentrating on things, such as reading 
the newspaper or watching television. 
0 
1 
2 
3 
8. Moving or speaking so slowly that other people 
could have noticed. Or the opposite – being so 
figety or restless that you have been moving 
around a lot more than usual 
0 
1 
2 
3 
9. Thoughts that you would be better off dead, or of 
hurting yourself. 
0 
1 
2 
3 
 
                
                ____  +  ____  +  ____ 
 
     
    TOTAL:_________________                    
10. If you checked off any problems, how difficult have 
these problems made it for you to do your work, 
take care of things at home, or get along with other 
people? 
• 
Not difficult at all ____ 
• 
Somewhat difficult ____ 
• 
Very difficult ____ 
• 
Extremely difficult ____