Chronic Obstructive Pulmonary DiseaseNCT01118104
Sickness Absence Versus Physical, Mental, and Job-related Factors in Patients With Chronic Pulmonary Disease
A study testing Vocational pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease and Asthma, run by LHL Helse at 1 site in Norway.
Trial summary
People with chronic respiratory disease have shortened work life, their disease is associated with greater work disability and they are at greater risk of being unemployed. Lower employment rates and higher sickness absence is expensive for the community and leads to financial as well as social consequences for the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma
- What is being tested?
- Vocational pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic pulmonary disease
- employed
- periods of sickness absence in the year prior to admittance
Who cannot join
- lack of ability to complete the rehabilitation program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationships Between Sickness Absence and Physical, Mental, and Job-related Factors in Patients With Chronic Pulmonary Disease
People with chronic respiratory disease have shortened work life, their disease is associated with greater work disability and they are at greater risk of being unemployed. Lower employment rates and higher sickness absence is expensive for the community and leads to financial as well as social consequences for the individual.
There is a lack of data on factors that can predict sickness absence and disability in patients with pulmonary disease. We therefore want to study a group of people with COPD and asthma referred to our clinic. The study will investigate relationships between sickness absence and exercise capacity, job-related factors, disease severity, self-efficacy, health related quality of life and subjective health complaints.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Being tested
- Vocational pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocational pulmonary rehabilitationOther
Multidisciplinary pulmonary rehabilitation with emphasis on vocational issues
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vocational rehabilitation | Other | Not described Receives: Other: Vocational pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects absent from work more than 10 days 4 weeks prior to follow-up
The subjects are interviewed after 12 months. Number of days absent from work during 4 weeks prior to the interview are recorded.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morten S Ryg, PhD, Study director, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118104
- Sponsor's protocol ID
- GK57
- Status last verified
- May 2012
- First submitted
- 27 Apr 2010
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Sickness Absence and Physical, Mental, and Job-related Factors in Patients With Chronic Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01118104
- Acronym / sponsor ID
- GK57
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with chronic respiratory disease have shortened work life, their disease is associated with greater work disability and they are at greater risk of being unemployed. Lower employment rates and higher sickness absence is expensive for the community and leads to financial as well as social consequences for the individual.
There is a lack of data on factors that can predict sickness absence and disability in patients with pulmonary disease. We therefore want to study a group of people with COPD and asthma referred to our clinic. The study will investigate relationships between sickness absence and exercise capacity, job-related factors, disease severity, self-efficacy, health related quality of life and subjective health complaints.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vocational rehabilitation | Other | Other: Vocational pulmonary rehabilitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic pulmonary disease
- employed
- periods of sickness absence in the year prior to admittance
Key exclusion criteria (1 listed)
- lack of ability to complete the rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vocational pulmonary rehabilitationMultidisciplinary pulmonary rehabilitation with emphasis on vocational issues | Other | Pulmonary vocational rehabilitation |
Primary outcome
Number of subjects absent from work more than 10 days 4 weeks prior to follow-up
Time frame: 12 months
The subjects are interviewed after 12 months. Number of days absent from work during 4 weeks prior to the interview are recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten S Ryg, PhD study director
LHL Helse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocational pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease and Asthma, run by LHL Helse at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects absent from work more than 10 days 4 weeks prior to follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.