Pulmonary Disease in a Psychiatric Inpatient Population

May 22, 2018 updated by: Principal Investigator, Nicolai Stig Renstrøm, Psykiatrien Syd

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vordingborg, Denmark, 4760
        • Psyciatrien Syd, Region Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: 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:
  • MicroLoop handheld transportable spirometer

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

This is where you will find people and organizations involved with this study.

Sponsor

Psykiatrien Syd

Collaborators

Naestved Hospital

Investigators

  • Principal Investigator: Nicolai Renstrom, Psykiatrien Syd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

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)?

No

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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