Chronic Obstructive Pulmonary DiseaseNCT00159549
Long Term Effect of an Education and Training Program for Patients With Chronic Obstructive Pulmonary Disease
A study testing education and training program in people with Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
A parallell group study comparing the effect of an education program with an education and training program for patients with COPD. 30 participants in each group. Participants self-select which group they wanted to be in. Main outcome is SGRQ (a HQoL for patients with COPD). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- education and training program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2000to Dec 2005
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with COPD (FEV1<75% of expected) who have the ability to conversation and active participation will be included.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Community Medicine and General Practice
Trondheim, N-7489
About this study
A parallell group study comparing the effect of an education program with an education and training program for patients with COPD. 30 participants in each group. Participants self-select which group they wanted to be in. Main outcome is SGRQ (a HQoL for patients with COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- education and training program
- Keywords
- Patient education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and training programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
St Geoprg Respiratory Questionnaire (SGRQ)
Secondary outcomes (1)
COPD-Efficacy scale (Norwegian short version), Breathing Problems Questionnaire (BPQ), journal examinations, FVC, FEV1, six minutes walking test with registration of shortness of breath and pulseoxymetrical data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2000
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Aslak Steinsbekk, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159549
- Sponsor's protocol ID
- DMF 05/414
- Status last verified
- Nov 2018
- First submitted
- 8 Sep 2005
- Last updated
- 30 Nov 2018
- Results posted
- No
Publications
Lomundal BK, Steinsbekk A. Observational studies of a one year self-management program and a two year pulmonary rehabilitation program in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2007;2(4):617-24.
PubMed 18268936Steinsbekk A, Lomundal BK. Three-year follow-up after a two-year comprehensive pulmonary rehabilitation program. Chron Respir Dis. 2009;6(1):5-11. doi: 10.1177/1479972308098387.
PubMed 19176707
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effect of an Education and Training Program for Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00159549
- Acronym / sponsor ID
- DMF 05/414
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Study start
- Jan 2000 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 12 Sep 2005 (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.
A parallell group study comparing the effect of an education program with an education and training program for patients with COPD. 30 participants in each group. Participants self-select which group they wanted to be in. Main outcome is SGRQ (a HQoL for patients with COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with COPD (FEV1<75% of expected) who have the ability to conversation and active participation will be included.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| education and training program | Behavioural | – |
Primary outcome
St Geoprg Respiratory Questionnaire (SGRQ)
1 secondary outcome
COPD-Efficacy scale (Norwegian short version), Breathing Problems Questionnaire (BPQ), journal examinations, FVC, FEV1, six minutes walking test with registration of shortness of breath and pulseoxymetrical data.
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 30 Nov 2018.
- Results publication: PubMed 18268936Lomundal BK, Steinsbekk A. Observational studies of a one year self-management program and a two year pulmonary rehabilitation program in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2007;2(4):617-24.
- Results publication: PubMed 19176707Steinsbekk A, Lomundal BK. Three-year follow-up after a two-year comprehensive pulmonary rehabilitation program. Chron Respir Dis. 2009;6(1):5-11. doi: 10.1177/1479972308098387.
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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.
Aslak Steinsbekk, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education and training program in people with Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology 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 1 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 30 Nov 2018. 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?
St Geoprg Respiratory Questionnaire (SGRQ). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159549, which also lists 2 linked publications.
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 30 Nov 2018; AzTrials last refreshed its copy on 31 Oct 2026.