- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823627
Pulmonary Disease in a Psychiatric Inpatient Population
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vordingborg, Denmark, 4760
- Psyciatrien Syd, Region Zealand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inpatients in Psykiatrien Syd, Region Zealand, ward S1,S2,S3,S4,S5,S6
- Admission time over 48 hours
Exclusion Criteria:
- Patients who is not able to perform spirometry due to their psychiatric condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Spirometry with reversibility test
|
Spirometry with reversibility test and CATest questionaire.
following will be measured FEV1 L/s FVC L/s FEV1/FVC ration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tiffeneau index
Time Frame: at enrollment
|
- FEV1/FVC ratio
|
at enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
forced vital capacity
Time Frame: at enrollment
|
FVC L/s
|
at enrollment
|
|
Forced expiratory volume in 1 second
Time Frame: at enrollment
|
FEV1 L
|
at enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicolai Renstrom, Psykiatrien Syd
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJ-322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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