NCT01823627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

March 26, 2013

Last Update Submit

May 22, 2018

Conditions

Keywords

COPDPsychiatric inpatientSmoking

Outcome Measures

Primary Outcomes (1)

  • Tiffeneau index

    \- FEV1/FVC ratio

    at enrollment

Secondary Outcomes (2)

  • forced vital capacity

    at enrollment

  • Forced expiratory volume in 1 second

    at enrollment

Study Arms (1)

Spirometry with reversibility test

OTHER

Spirometry with reversibility test

Procedure: Spirometry with reversibility test

Interventions

Spirometry with reversibility test and CATest questionaire. following will be measured FEV1 L/s FVC L/s FEV1/FVC ration

Also known as: MicroLoop handheld transportable spirometer
Spirometry with reversibility test

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients in Psykiatrien Syd, Region Zealand, ward S1,S2,S3,S4,S5,S6
  • Admission time over 48 hours

You may not qualify if:

  • Patients who is not able to perform spirometry due to their psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psyciatrien Syd, Region Zealand

Vordingborg, 4760, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSmoking

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Nicolai Renstrom

    Psykiatrien Syd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
1.Reservelæge

Study Record Dates

First Submitted

March 26, 2013

First Posted

April 4, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

May 24, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations