Indoor air quality and health – the K-HEALTHinAIR project

ISRCTN	ISRCTN10927320
DOI	https://doi.org/10.1186/ISRCTN10927320
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	101057693
Sponsors	Cartif, Erasmus MC
Funder	European Health and Digital Executive Agency

Submission date: 05/09/2023
Registration date: 15/09/2023
Last edited: 25/11/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The negative impact of outdoor air pollution and indoor air quality on health is well-accepted. However, the current knowledge on the health effects of impaired indoor air quality shows numerous gaps (e.g. previous studies cover limited parameters, limited scenarios or are limited in time). Therefore the Knowledge for improving indoor AIR quality and HEALTH (K-HEALTHinAIR) project aims to address these gaps by studying determinants of the effect of indoor air quality on health covering multiple parameters in nine relevant scenarios in six European countries with a project duration of 3 years.
The overall K-HEALTHinAIR project objectives are:
1. Identifying the determinants of indoor air quality and health, and the association between indoor air quality and health, by monitoring indoor air quality and performing big data analyses
2. Confirming the identified determinants and search for their sources by monitoring indoor air quality, performing big data analysis and using supporting studies
3. Testing preventive interventions using continued monitoring of indoor air quality and using reference spaces and theoretical analysis to evaluate interventions.
This registration is for the K-HEALTHinAIR Rotterdam pilot study. The primary objective of the Rotterdam pilot is to study the determinants of indoor air quality and its associations with health and well-being among older adults.

Who can participate?
Older adults (aged 60+ years) living at home. The participants will be recruited in Erasmus Medical Centre (EMC) outpatient clinics (e.g. department of geriatrics, internal medicine, and pulmonary medicine) and in collaboration with senior housing cooperations.

What does the study involve?
Using self-report questionnaires older adults will report on their (general) health and wellbeing and indoor air quality related behavior at the start of the study and at 6 and 12 months of follow-up. A two-page questionnaire on health symptoms related to indoor air quality is completed every 2 months.

What are the possible benefits and risks of participating?
This is a non-invasive study and there are low risks associated with participation. The study involves non-invasive measurements that do not affect the physical and/or psychological integrity of the participants. Participants can withdraw from participation at any time during the study without having to explain why to the research team.

Where is the study run from?
Erasmus Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
September 2022 to September 2026

Who is funding the study?
European Union - the European Health and Digital Executive Agency (HADEA) as part of HORIZON HEALTH 2021

Who is the main contact?
The main contact of the overall K-HEALTHinAIR project is josdom@cartif.es
The two contacts for the K-HEALTHinAIR Rotterdam pilot study are Amy van Grieken (a.vangrieken@erasmusmc.nl) and Simon de Leede (s.c.deleede@erasmusmc.nl)

Contact information

Dr Amy van Grieken
Principal investigator

Dr. Molewaterplein 40
Rotterdam
3000CA
Netherlands

ORCID ID	0000-0001-6767-9159
Phone	+31 (0)10 704 0 704
Email	a.vangrieken@erasmusmc.nl

Dr Simon de Leede
Scientific

Dr. Molewaterplein
Rotterdam
3000CA
Netherlands

ORCID ID	0009-0008-1929-6100
Phone	+31 (0)107045696
Email	s.c.deleede@erasmusmc.nl

Study information

Primary study design	Observational
Study design	The Rotterdam pilot study uses mixed methods in a small size prospective cohort study, namely self-report questionnaires, a non-intrusive household indoor air quality monitoring device and an observational checklist.
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Knowledge for improving indoor air quality and health - Rotterdam study
Study acronym	K-HEALTHinAIR-Rotterdam
Study objectives	The primary objective of the K-HEALTHinAIR Rotterdam pilot is to study the determinants of indoor air quality and its associations with health and well-being among older adults. The Rotterdam study is part of the larger K-HEALTHinAIR project funded by grant nr. 101057693. The information below all refers to the Rotterdam pilot study as part of the larger K-HEALTHinAIR project.
Ethics approval(s)	1. Approved 17/05/2023, Non-WMO Review Committee (Niet WMO Toetsingscommissie) (Dr. Molewaterplein 40, Rotterdam, 3000CA, Netherlands; +31 (0)107033625; metc@erasmusmc.nl), ref: MEC-2023-0293 2. Approved 25/08/2025, Non-WMO Review Committee (Niet WMO Toetsingscommissie) (Dr. Molewaterplein 40, Rotterdam, 3000 CA, Netherlands; +31 (0)107033625; metc@erasmusmc.nl), ref: MEC-2025-0388
Health condition(s) or problem(s) studied	General health and well-being in older adults (aged 60+ years) and older adults with pulmonary complaints
Intervention	Observational methodology and assessments: 1. Indoor air quality (e.g. particle matter, volatile organic compounds) continuously monitored with air quality sensors 2. Health and well-being (e.g. health complaints, mental health, quality of life, falls) assessed by self-report questionnaire 3. Indoor environment (e.g. cooking type, windows present etc) assessed by observational checklist 4. Indoor air quality related behavior (e.g. opening windows) assessed by self-report questionnaire For the first year, the observations are as follows: Month 0: installation of MICA device, administering of observational checklist and larger questionnaire Month 2: diary questions, 5 days in a row Month 4: diary questions, 5 days in a row Month 6: larger questionnaire Month 8: diary questions, 5 days in a row Month 10: diary questions, 5 days in a row Month 12: larger questionnaire Added 25/11/2025: For the follow-up study of 6 months, the observations are as follows: Month 0: baseline questionnaire, 7-day diary Month 1,5: 2-week intervention Month 2: interviews with select sample, 7-day diary Month 2,5: 2-week intervention Month 3: interview with select sample, first follow-up questionnaire, 7-day diary Month 6: interview with select sample, second follow-up questionnaire, 7-day diary Within the 6-month follow-up study, a select sample of n = 10 participants will use a portable air quality monitoring tool for 7 days in a row. Before and after using the portable tool interviews will take place to evaluate expectations and experiences.
Intervention type	Mixed
Primary outcome measure(s)	First-year study: 1. Quality of life measured using EQ-5D-5L at baseline, 6-month and 12-month follow-up. 2. Mental health measured using PHQ-9 at baseline, 6-month and 12-month follow-up. 3. Indoor air quality (IAQ)-related health symptoms measured using a diary at months 2, 4, 8 and 10 After the 12-month follow-up, the researchers will assess which measurements will be administered and at what frequency for years 2 and 3 of the study. They will update the registration once they have this information Added 25/11/2025: Follow-up study: 1. Quality of life measured using EQ-5D-5L at baseline, 3- and 6-month follow-up. 2. Mental health measured using PHQ-8 at baseline, 3- and 6-month follow-up. 3. Indoor air quality (IAQ)-related health symptoms measured using a diary at baseline, month 2, 3 and 6
Key secondary outcome measure(s)	1. Indoor air quality measured with MICA devices that measure IAQ continuously for 36 months 2. Indoor air quality related behavior (e.g. opening windows) assessed using a questionnaire every 6 months 3. Measured using International Consortium for Health Outcomes Measurement (ICHOM) adult and older set (combination) at baseline, 6-month and 12-month follow-up: 3.1. Medication and care use 3.2. Falls 3.3. Lifestyle 4. Living situation (perceived IAQ and outdoor air quality [OAQ], window opening, time spent in scenario) measured at baseline, 6-month and 12-month follow-up 5. Time spent at home measured using a diary at months 2, 4, 8 and 10 After the 12-month follow-up, the researchers will assess which measurements will be administered and at what frequency for years 2 and 3 of the study. They will update the registration once they have this information Added 25/11/2025: Follow-up study: 1. Indoor air quality measured with MICA devices that measure IAQ continuously for 6 months 2. Indoor air quality related behavior (e.g. opening windows) assessed using a questionnaire at baseline, 3 and 6 months 3. Living situation (perceived IAQ and outdoor air quality [OAQ], window opening) measured at baseline, 3- and 6-month follow-up, and the diaries 4. Time spent at home measured using diaries at baseline, month 2, 3 and 6
Completion date	01/09/2026

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Lower age limit	60 Years
Upper age limit	110 Years
Sex	All
Target sample size at registration	110
Total final enrolment	109
Key inclusion criteria	1. 60+ years old 2. Cognitively capable of providing informed consent 3. Understand the Dutch language
Key exclusion criteria	1. Not able to comprehend the information provided in Dutch 2. Unable or unwilling to give informed consent 3. Unable to cognitively evaluate the risks and benefits of participation
Date of first enrolment	07/01/2024
Date of final enrolment	30/11/2025

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus MC

Dr. Molewaterplein 40
Rotterdam
3000CA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/11/2025: The following changes were made to the study record:
1. The ethics approval, interventions, primary/secondary outcomes and contact details were updated.
2. The date of final enrolment was changed from 20/09/2025 to 30/11/2025.
04/07/2025: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The date of first enrolment was changed from 20/09/2023 to 07/01/2024.
3. The date of final enrolment was changed from 20/03/2024 to 20/09/2025.
26/09/2023: Internal review.
07/09/2023: Study's existence confirmed by the Non-WMO Review Committee.