Pulmonary Disease in a Psychiatric Inpatient Population | NCT01823627

Studies
Pulmonary Disease in a Psychiatric Inpatient Population

NCT01823627

Sponsor

Psykiatrien Syd

Status

Completed

Last Update Posted

May 24, 2018Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Airway Disease

Interventions

Spirometry with reversibility test

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

Apr 2, 2013

First Posted Date

Apr 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2018

Last Update Posted Date

May 24, 2018Actual

Name	Class
Naestved Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spirometry with reversibility test	Other	Spirometry with reversibility test	Procedure: Spirometry with reversibility test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spirometry with reversibility test	Procedure	Spirometry with reversibility test and CATest questionaire. following will be measured FEV1 L/s FVC L/s FEV1/FVC ration	Spirometry with reversibility test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tiffeneau index	- FEV1/FVC ratio	at enrollment

Secondary Outcomes

Measure	Description	Time Frame
forced vital capacity	FVC L/s	at enrollment
Forced expiratory volume in 1 second	FEV1 L	at enrollment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolai Renstrom	Psykiatrien Syd	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psyciatrien Syd, Region Zealand		Vordingborg		4760	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D012907	Smoking

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided