NCT04427579

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 15, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

5.5 years

First QC Date

June 8, 2020

Last Update Submit

June 9, 2020

Conditions

COPDAnxiety DisordersDepressive Disorder

Keywords

MetacognitionsHospital Anxiety and Depression Scale

Outcome Measures

Primary Outcomes (2)

  • COPD exacerbation rate

    The number of moderate or severe exacerbations

    3 years

  • Mortality rate

    The number of deaths

    3 years

Secondary Outcomes (1)

  • Assessment of Health-related Quality of Life With RAND-36

    3 years

Other Outcomes (2)

  • The prevalence of anxiety disorder

    1 year

  • The prevalence of depressive disorder

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Acute exacerbated phase of COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHL-hospital Gardermoen

Jessheim, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety DisordersDepressive DisorderDepression

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gunnar Einvik, PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doc candidate, MD

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

June 15, 2018

Primary Completion

December 1, 2023

Study Completion

December 1, 2025

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)