Pulmonary Disease in a Psychiatric Inpatient Population
Primary Purpose
Chronic Obstructive Airway Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Spirometry with reversibility test
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Airway Disease focused on measuring COPD, Psychiatric inpatient, Smoking
Eligibility Criteria
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
Sites / Locations
- Psyciatrien Syd, Region Zealand
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Spirometry with reversibility test
Arm Description
Spirometry with reversibility test
Outcomes
Primary Outcome Measures
Tiffeneau index
- FEV1/FVC ratio
Secondary Outcome Measures
forced vital capacity
FVC L/s
Forced expiratory volume in 1 second
FEV1 L
Full Information
NCT ID
NCT01823627
First Posted
March 26, 2013
Last Updated
May 22, 2018
Sponsor
Psykiatrien Syd
Collaborators
Naestved Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01823627
Brief Title
Pulmonary Disease in a Psychiatric Inpatient Population
Official Title
Pulmonary Disease in a Psychiatric Inpatient Population, a Screening Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psykiatrien Syd
Collaborators
Naestved Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Airway Disease
Keywords
COPD, Psychiatric inpatient, Smoking
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spirometry with reversibility test
Arm Type
Other
Arm Description
Spirometry with reversibility test
Intervention Type
Procedure
Intervention Name(s)
Spirometry with reversibility test
Other Intervention Name(s)
MicroLoop handheld transportable spirometer
Intervention Description
Spirometry with reversibility test and CATest questionaire. following will be measured FEV1 L/s FVC L/s FEV1/FVC ration
Primary Outcome Measure Information:
Title
Tiffeneau index
Description
- FEV1/FVC ratio
Time Frame
at enrollment
Secondary Outcome Measure Information:
Title
forced vital capacity
Description
FVC L/s
Time Frame
at enrollment
Title
Forced expiratory volume in 1 second
Description
FEV1 L
Time Frame
at enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolai Renstrom
Organizational Affiliation
Psykiatrien Syd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psyciatrien Syd, Region Zealand
City
Vordingborg
ZIP/Postal Code
4760
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Pulmonary Disease in a Psychiatric Inpatient Population
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