COPDNCT04427579
Anxiety and Depression in COPD; Prevalence, Detection and Prognosis
An observational study of COPD and Anxiety Disorders, run by University Hospital, Akershus at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Anxiety Disorders, Depressive Disorder
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jun 2018to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults referred to and initiating a 2-4 weeks in-hospital rehabilitation course.
Who may be able to join
- Participant in in-hospital pulmonary rehabilitation at LHL-hospital Gardermoen
- Diagnosis of COPD
Who cannot join
- Acute exacerbated phase of COPD
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- COPD, Anxiety Disorders, Depressive Disorder
- Keywords
- Metacognitions, Hospital Anxiety and Depression Scale
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Depressive Disorder, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD exacerbation rate
The number of moderate or severe exacerbations
Measured: 3 years
Mortality rate
The number of deaths
Measured: 3 years
Secondary outcomes (1)
Assessment of Health-related Quality of Life With RAND-36
The total score and subscale scores on RAND 36
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Jun 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, LHL Hospital Gardermoen, Priory Hospital Altrincham
- Responsible party
- Principal investigator, Gunnar Einvik, University Hospital, Akershus
- Investigators
- Gunnar Einvik, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427579
- Sponsor's protocol ID
- 2018/149
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Depression in COPD; Prevalence, Detection and Prognosis
- ClinicalTrials.gov ID
- NCT04427579
- Acronym / sponsor ID
- 2018/149
- Conditions
- COPD, Anxiety Disorders, Depressive Disorder
- Keywords
- Metacognitions, Hospital Anxiety and Depression Scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo, LHL Hospital Gardermoen, Priory Hospital Altrincham
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults referred to and initiating a 2-4 weeks in-hospital rehabilitation course.
Key inclusion criteria (2 listed)
- Participant in in-hospital pulmonary rehabilitation at LHL-hospital Gardermoen
- Diagnosis of COPD
Key exclusion criteria (1 listed)
- Acute exacerbated phase of COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COPD exacerbation rate
Time frame: 3 years
The number of moderate or severe exacerbations
Mortality rate
Time frame: 3 years
The number of deaths
1 secondary outcome
Assessment of Health-related Quality of Life With RAND-36
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Einvik, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Anxiety Disorders, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD exacerbation rate (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.