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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
Psykiatrien Syd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Airway Disease focused on measuring COPD, Psychiatric inpatient, Smoking

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
March 26, 2013
Last Updated
May 22, 2018
Sponsor
Psykiatrien Syd
Collaborators
Naestved Hospital
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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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