Pulmonary Disease, Chronic ObstructiveNCT00932711
Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease
A study testing Educational brochures in people with Pulmonary Disease, Chronic Obstructive, run by VA Midwest Health Care Network at 1 site in United States.
Trial summary
The purpose of this study is to determine if educational intervention is effective in reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Educational brochures
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Spirometrically confirmed COPD in VISN23 registry. FEV1/FVC <70%.
Exclusion Criteria:Hospital admissions or ED visits in the VISN23 disease registry for COPD within last one year
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
About this study
Official title: Limited Intervention in Low Risk(Tier 3) COPD Patients
The purpose of this study is to determine if educational intervention is effective in reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk disease.
Read the detailed description
There is growing evidence about the effectiveness of case management in preventing adverse events in patients with high-risk chronic obstructive pulmonary disease(COPD). But the majority of COPD patients belong to the low-risk category. We propose that a less intense educational intervention will have a similar beneficial effect in reducing hospital admissions and emergency department (ED) visits in this larger group of low-risk COPD patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Educational brochures
- Keywords
- COPD
- 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.
Educational brochuresBehavioural
A locally developed educational brochure containing information about smoking cessation, influenza and pneumococcal vaccination, regular exercise, compliance with prescribed COPD therapy and recognition of symptoms, along with a goal setting questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | Subjects in this group will receive educational brochures about management of COPD Receives: Behavioral: Educational brochures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined frequency of admissions and ED visits for COPD over 1 year.
Measured: One year
Secondary outcomes (2)
Patient knowledge of COPD will be compared.
Measured: 1 year
Use of respiratory medications will be compared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Midwest Health Care Network
- Sponsor type
- US federal agency
- Investigators
- Kathryn Rice, MD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932711
- Sponsor's protocol ID
- 4140-B
- Status last verified
- Jun 2009
- First submitted
- 2 Jul 2009
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limited Intervention in Low Risk(Tier 3) COPD Patients
- ClinicalTrials.gov ID
- NCT00932711
- Acronym / sponsor ID
- 4140-B
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- VA Midwest Health Care NetworkUS federal agency
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 3 Jul 2009 (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.
The purpose of this study is to determine if educational intervention is effective in reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk disease.
Detailed description
There is growing evidence about the effectiveness of case management in preventing adverse events in patients with high-risk chronic obstructive pulmonary disease(COPD). But the majority of COPD patients belong to the low-risk category. We propose that a less intense educational intervention will have a similar beneficial effect in reducing hospital admissions and emergency department (ED) visits in this larger group of low-risk COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Behavioral: Educational brochuresSubjects in this group will receive educational brochures about management of COPD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Educational brochuresA locally developed educational brochure containing information about smoking cessation, influenza and pneumococcal vaccination, regular exercise, compliance with prescribed COPD therapy and recognition of symptoms, along with a goal setting questionnaire | Behavioural | Educational intervention |
Primary outcome
Combined frequency of admissions and ED visits for COPD over 1 year.
Time frame: One year
2 secondary outcomes
Patient knowledge of COPD will be compared.
Time frame: 1 year
Use of respiratory medications will be compared
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2009.
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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.
Kathryn Rice, MD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational brochures in people with Pulmonary Disease, Chronic Obstructive, run by VA Midwest Health Care Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2009. 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 United States. 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?
Results are not available in the source record.
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?
Combined frequency of admissions and ED visits for COPD over 1 year. (time frame: One year). 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 3 Jul 2009.