Indoor air quality and health – the K-HEALTHinAIR project

ISRCTN ISRCTN10927320
DOI https://doi.org/10.1186/ISRCTN10927320
Secondary identifying numbers 101057693
Submission date
05/09/2023
Registration date
15/09/2023
Last edited
26/09/2023
Recruitment status
No longer 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

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 Dr Suzanne van den Toren (s.vandentoren@erasmusmc.nl)

Study website

Contact information

Dr Amy van Grieken
Principal Investigator

Dr. Molewaterplein 40
Rotterdam
3000CA
Netherlands

ORCiD logoORCID ID 0000-0001-6767-9159
Phone +31 (0)10 704 0 704
Email a.vangrieken@erasmusmc.nl
Dr Suzanne van den Toren
Scientific

Dr. Molewaterplein
Rotterdam
3000CA
Netherlands

ORCiD logoORCID ID 0000-0002-0452-9812
Phone +31 (0)10 704 0 704
Email s.vandentoren@erasmusmc.nl

Study information

Study designThe 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.
Primary study designObservational
Secondary study designCohort study
Study setting(s)Built environment/local authority, Community, Home, Hospital
Study typePrevention, Quality of life
Participant information sheet Not available in web format, please use contact details to request participant information sheet
Scientific titleKnowledge for improving indoor air quality and health - Rotterdam study
Study acronymK-HEALTHinAIR-Rotterdam
Study hypothesisThe 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)

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

ConditionGeneral health and well-being in older adults (aged 60+ years) and older adults with pulmonary complaints
InterventionObservational 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
Intervention typeMixed
Primary outcome measure1. 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.
Secondary outcome measures1. 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.
Overall study start date01/09/2022
Overall study end date01/09/2026

Eligibility

Participant type(s)Healthy volunteer
Age groupSenior
Lower age limit60 Years
Upper age limit110 Years
SexBoth
Target number of participants110
Participant inclusion criteria1. 60+ years old
2. Cognitively capable of providing informed consent
3. Understand the Dutch language
Participant exclusion criteria1. 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
Recruitment start date20/09/2023
Recruitment end date20/03/2024

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus MC
Dr. Molewaterplein 40
Rotterdam
3000CA
Netherlands

Sponsor information

Cartif
Research organisation

47151 Boecillo
Valladolid
Av. Francisco Vallés, 4
Spain

Phone +34 (0)983 54 65 04
Email josdom@cartif.es
Website http://www.cartif.com/en/
ROR logo "ROR" https://ror.org/036krsg33
Erasmus MC
Hospital/treatment centre

Dr. Molewaterplein 40
Rotterdam
3000CA
Netherlands

Phone +31 (0)10 704 0 704
Email secretariaat.mgz@erasmusmc.nl
Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Other

European Health and Digital Executive Agency
Government organisation / National government
Alternative name(s)
Health and Digital Executive Agency, HaDEA

Results and Publications

Intention to publish date01/09/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

26/09/2023: Internal review.
07/09/2023: Study's existence confirmed by the Non-WMO Review Committee.