Condition category
Respiratory
Date applied
10/07/2012
Date assigned
30/08/2012
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kirsi Karvala

ORCID ID

Contact details

Finnish Institute of Occupational Health
Topeliuksenkatu 41 a A
Helsinki
FI-00250
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Work related respiratory disease due to indoor air and work ability: a randomized controlled trial

Acronym

Study hypothesis

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

Coordinating Ethics Committee of Hospital District of Helsinki and Uusimaa, 27/04/2010, ref: 61/13/03/00/2010, amendment approved 11/11/2011

Study design

Single-center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patient refusal
2. Not actively participating working life (retired or unemployed)

Recruitment start date

01/08/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Finland

Trial participating centre

Finnish Institute of Occupational Health
Helsinki
FI-00250
Finland

Sponsor information

Organisation

Finnish Institute of Occupational Health (Finland)

Sponsor details

Topeliuksenkatu 41 a A
Helsinki
FI-00250
Finland

Sponsor type

Government

Website

http://www.ttl.fi/en/

Funders

Funder type

Government

Funder name

Finnish Institute of Occupational Health (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26014487

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added.