Work related respiratory disease due to indoor air and work ability
| ISRCTN | ISRCTN33165676 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33165676 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/07/2012
- Registration date
- 30/08/2012
- Last edited
- 05/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims:
Indoor air problems in non industrial work environments are associated with respiratory health problems. Symptoms are usually temporary, but long-lasting symptoms and work limitation are common in some individuals despite building repairs or moving an alternative work environment. Our goal is to see if better symptom management will result in better work ability and less sickness absences. We want to develop strategies for occupational health professionals to support work ability.
Who can participate?
The study recruits patients referred to the Finnish Institute of Occupational Health due to suspected respiratory disease related to workplace dampness and other indoor air problems. We recruit patients who experience reduced work ability and who have had sick leaves due to indoor air symptoms.
What does the study involve?
Two groups of 30 patients each will be created. 30 patients will be allocated to the better symptom management group, where they will receive objective information (given by a physician) about indoor air symptoms and their mechanisms. They will also get psychological training about symptom management. The other 30 patients will undergo only customary examinations, which are needed to assess the possibility of an occupational disease. At the beginning of the study and after six months, we will compare the work ability, the amount of sick leave days, the quality of life and illness worries between the groups by a questionnaire.
What are the possible benefits and risks of participating?
Those who are taking part will learn to improve symptom management. Participating causes no harm to the patient.
Where is the study run from?
The Finnish Institute of Occupational Health
When is the study starting and how long is it expected to runs for?
The pilot phase started in January 2012. The study will start in August 2012 and will run for 5 months or until the required number of 30 intervention and 30 control patients has been recruited.
Who is funding the study?
The Finnish Ministry of Social Affairs and Health, and the Finnish Institute of Occupational Health.
Who is the main contact?
Dr Kirsi Karvala
kirsi.karvala@ttl.fi
Contact information
Scientific
Finnish Institute of Occupational Health
Topeliuksenkatu 41 a A
Helsinki
FI-00250
Finland
Study information
| Study design | Single-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Work related respiratory disease due to indoor air and work ability: a randomized controlled trial |
| Study objectives | Effective patient information on indoor air symptoms and asthma management, combined to a psychological intervention using methods of cognitive and motivational psychology, will lead to less disability days, better self-assessed work ability and quality of life. |
| Ethics approval(s) | Coordinating Ethics Committee of Hospital District of Helsinki and Uusimaa, 27/04/2010, ref: 61/13/03/00/2010, amendment approved 11/11/2011 |
| Health condition(s) or problem(s) studied | Respiratory disorders |
| Intervention | Intervention: Effective patient information on indoor air symptoms and asthma management, combined to a psychological intervention using methods of cognitive and motivational psychology. Control: Only usual examinations to assess if the patient has an occupational disease without an intervention |
| Intervention type | Other |
| Primary outcome measure | 1. Self-assessed work ability (on a scale 0-10) 2. Total number of sick leave days during the past six months |
| Secondary outcome measures | 1. Quality of life (RAND-36) 2. Illness worries (Ilness Worry Scale IWS) |
| Overall study start date | 01/08/2012 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Patients who are referred to the Finnish Institute of Occupational Health because of a suspicion of an occupational respiratory disease related to workplace indoor air (non-industrial workplaces) 2. Minimum of 14 days on sick leave due to indoor air symptoms during the preceding year 3. Self-assessed work ability not more than 7 (on a scale 0-10, compared to lifetime best) |
| Key exclusion criteria | 1. Patient refusal 2. Not actively participating working life (retired or unemployed) |
| Date of first enrolment | 01/08/2012 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Finland
Study participating centre
FI-00250
Finland
Sponsor information
Government
Topeliuksenkatu 41 a A
Helsinki
FI-00250
Finland
| Website | http://www.ttl.fi/en/ |
|---|---|
"ROR" |
https://ror.org/030wyr187 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2015 | Yes | No |
Editorial Notes
05/05/2016: Publication reference added.
