Chronic Obstructive Airway DiseaseNCT01823627
Pulmonary Disease in a Psychiatric Inpatient Population
A study testing Spirometry with reversibility test in people with Chronic Obstructive Airway Disease, run by Psykiatrien Syd at 1 site in Denmark.
Trial summary
Purpose: Patients with mental health disorders have a reduced life expectancy, compared to the general population. The shorter life expectancy is caused by natural and unnatural death. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Airway Disease
- What is being tested?
- Spirometry with reversibility test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2013to Jul 2013
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inpatients in Psykiatrien Syd, Region Zealand, ward S1,S2,S3,S4,S5,S6
- Admission time over 48 hours
Who cannot join
- Patients who is not able to perform spirometry due to their psychiatric condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Disease in a Psychiatric Inpatient Population, a Screening Study
Purpose: Patients with mental health disorders have a reduced life expectancy, compared to the general population. The shorter life expectancy is caused by natural and unnatural death. In general, patients with a mental disorder tend to have a more unhealthy lifestyle, than the general population, characterized by e.g. lack of exercise and smoking.
Hypothesis
Read more
Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients There is a higher prevalence of COPD in psychiatric inpatients compared to the general population Screening of patients with one respiratory symptom and a smoking history, has the same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking history
Method:
80 psychiatric inpatients will undergo spirometry with reversibility test and COPD Assessment Test (CATest). Furthermore, patient history regarding respiratory symptoms and smoking will be taken into account.
- Conditions
- Chronic Obstructive Airway Disease
- Being tested
- Spirometry with reversibility test
- Keywords
- COPD, Psychiatric inpatient, Smoking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry with reversibility testProcedure or surgery
Also called MicroLoop handheld transportable spirometer
Spirometry with reversibility test and CATest questionaire. following will be measured FEV1 L/s FVC L/s FEV1/FVC ration
| Study group | Role | What they receive |
|---|---|---|
| Spirometry with reversibility test | Other | Spirometry with reversibility test Receives: Procedure: Spirometry with reversibility test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tiffeneau index
- FEV1/FVC ratio
Measured: at enrollment
Secondary outcomes (2)
forced vital capacity
FVC L/s
Measured: at enrollment
Forced expiratory volume in 1 second
FEV1 L
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airway 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psykiatrien Syd
- Sponsor type
- University, hospital or other
- Collaborators
- Naestved Hospital
- Responsible party
- Principal investigator, Principal Investigator, Nicolai Stig Renstrøm, Psykiatrien Syd
- Investigators
- Nicolai Renstrom, Principal investigator, Psykiatrien Syd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823627
- Sponsor's protocol ID
- SJ-322
- Status last verified
- May 2018
- First submitted
- 26 Mar 2013
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Disease in a Psychiatric Inpatient Population, a Screening Study
- ClinicalTrials.gov ID
- NCT01823627
- Acronym / sponsor ID
- SJ-322
- Conditions
- Chronic Obstructive Airway Disease
- Keywords
- COPD, Psychiatric inpatient, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Psykiatrien SydUniversity, hospital or other
- Collaborators
- Naestved Hospital
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Apr 2013 (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.
Purpose: Patients with mental health disorders have a reduced life expectancy, compared to the general population. The shorter life expectancy is caused by natural and unnatural death. In general, patients with a mental disorder tend to have a more unhealthy lifestyle, than the general population, characterized by e.g. lack of exercise and smoking.
Hypothesis
Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients There is a higher prevalence of COPD in psychiatric inpatients compared to the general population Screening of patients with one respiratory symptom and a smoking history, has the same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking history
Method:
80 psychiatric inpatients will undergo spirometry with reversibility test and COPD Assessment Test (CATest). Furthermore, patient history regarding respiratory symptoms and smoking will be taken into account.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spirometry with reversibility test | Other | Procedure: Spirometry with reversibility testSpirometry with reversibility test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatients in Psykiatrien Syd, Region Zealand, ward S1,S2,S3,S4,S5,S6
- Admission time over 48 hours
Key exclusion criteria (1 listed)
- Patients who is not able to perform spirometry due to their psychiatric condition
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 |
|---|---|---|
| Spirometry with reversibility testAlso: MicroLoop handheld transportable spirometerSpirometry with reversibility test and CATest questionaire. following will be measured FEV1 L/s FVC L/s FEV1/FVC ration | Procedure or surgery | Spirometry with reversibility test |
Primary outcome
Tiffeneau index
Time frame: at enrollment
- FEV1/FVC ratio
2 secondary outcomes
forced vital capacity
Time frame: at enrollment
Forced expiratory volume in 1 second
Time frame: at enrollment
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 24 May 2018.
- Individual participant dataSharing planned: No
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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.
Nicolai Renstrom principal investigator
Psykiatrien Syd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry with reversibility test in people with Chronic Obstructive Airway Disease, run by Psykiatrien Syd at 1 site in Denmark.
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 2 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 24 May 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 Denmark. 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?
Tiffeneau index (time frame: at enrollment). 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 24 May 2018.