Anxiety and Depression in COPD; Prevalence, Detection and... | NCT04427579

Studies
Anxiety and Depression in COPD; Prevalence, Detection and Prognosis

NCT04427579

Sponsor

University Hospital, Akershus

Status

Unknown status

Last Update Posted

Jun 11, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

COPD
Anxiety Disorders
Depressive Disorder

Interventions

Not provided

Countries

Norway

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2018Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jun 8, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 11, 2020Actual

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

Jun 9, 2020

Last Update Posted Date

Jun 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gunnar Einvik, Post-doc candidate, MD, University Hospital, AkershusPrincipal Investigator

Lead Sponsor

University Hospital, AkershusOTHER

Collaborators

Name	Class
University of Oslo	OTHER
LHL Hospital Gardermoen	UNKNOWN
Priory Hospital Altrincham	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The current cohort study of 300 stable COPD patients aims to assess the following topics:

The prevalence of anxiety and depressive disorders in patients with COPD
The screening properties of Hospital Anxiety and Depression Scale in patients with COPD
The prognostic influence by anxiety or depressive symptoms and anxiety or depressive disorder.
whether characterization of 1) affective aspects of dyspnea symptoms or 2) persistent styles of thinking (worry or rumination) and metacognitions that drive these may improve the current recommendation of screening for anxiety and depression in COPD in relation to its clinical relevance on functional status and three year outcome

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COPD exacerbation rate	The number of moderate or severe exacerbations	3 years
Mortality rate	The number of deaths	3 years

Secondary Outcomes

Measure	Description	Time Frame
Assessment of Health-related Quality of Life With RAND-36	The total score and subscale scores on RAND 36	3 years

Other Outcomes

Measure	Description	Time Frame
The prevalence of anxiety disorder	Clinically diagnosed anxiety disorders	1 year
The prevalence of depressive disorder	Clinically diagnosed depressive disorder

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant in in-hospital pulmonary rehabilitation at LHL-hospital Gardermoen
Diagnosis of COPD

Exclusion Criteria:

Acute exacerbated phase of COPD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adults referred to and initiating a 2-4 weeks in-hospital rehabilitation course.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar Einvik, PhD	University Hospital, Akershus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LHL-hospital Gardermoen		Jessheim			Norway

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
D001008	Anxiety Disorders
D003866	Depressive Disorder
D003863	Depression

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