DepressionNCT02415140
Prevalence and Predictors of Depression in COPD
An observational study of Depression and COPD, run by Kwong Wah Hospital.
Trial summary
Depression adversely affects quality of life in COPD patients, associated with higher rate of exacerbations, admissions and mortality. However, local prevalence rate of depression in geriatric COPD patients remains unknown. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, COPD
- What is being tested?
- Rate of depression
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Feb 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients with spirometry confirmed airflow limitation
Who may be able to join
- aged 60 or above,
- with stable COPD suggested clinically and
- post-bronchodilator spirometry FEV1/FVC ratio <0.7.
Who cannot join
- Patients were excluded if they had co-existing pulmonary diseases like active pulmonary tuberculosis, interstitial lung diseases etc;
- if they were too demented or physically incapacitated to participate e.g wheelchair-bound for bedbound.
About this study
Official title: Prevalence and Independent Predictors of Depression in COPD
Depression adversely affects quality of life in COPD patients, associated with higher rate of exacerbations, admissions and mortality. However, local prevalence rate of depression in geriatric COPD patients remains unknown.
Though BODE index is superior to FEV1 in prediction of depression in COPD, it is unclear which domain of BODE correlates best with depression. Furthermore, with multiple confounding factors, it's ambiguous that whether frequent exacerbation is an 'independent' predictor for depression among COPD patients.
The objective of this study is i.) to study the local prevalence rate of depression in geriatric COPD patients, ii.) to identify risk factors for depression especially looking at the any independent relationship between frequent exacerbations, various domains of BODE index and depression.
Read the detailed description
This study is a multi-centers, cross-sectional study, conducted in Kwong Wah Hospital and Wong Tai Sin Hospital, Hong Kong SAR. Age and comorbidity-matched COPD and control subjects were recruited from clinics. Depressive symptoms were measured by a validated Chinese version of Geriatric Depression Scale short form (GDS - 15 items) with 2 cut-off points. A score of 8 or above was considered significant depressive symptoms while the cut off score of 5 or above was for patients with mild depressive symptoms. Prevalence rates of depressive symptoms were measured in both COPD and control groups. Predictors for depression (GDS = or> 8) were determined using univariate and multivariate analysis.
- Conditions
- Depression, COPD
- Being tested
- Rate of depression
- Medical subject headings
- Depression, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate of depressionOther
| Study group | Role | What they receive |
|---|---|---|
| COPD | Spirometry confirmed COPD patients Receives: Other: Rate of depression | |
| Control | normal geriatric patients without lung disease Receives: Other: Rate of depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depression (Prevalence rate)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwong Wah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tse Hoi Nam, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415140
- Sponsor's protocol ID
- KW/EX-13-142 (70-02)
- Status last verified
- Apr 2015
- First submitted
- 8 Apr 2015
- Last updated
- 14 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Independent Predictors of Depression in COPD
- ClinicalTrials.gov ID
- NCT02415140
- Acronym / sponsor ID
- KW/EX-13-142 (70-02)
- Conditions
- Depression, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Kwong Wah HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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.
Depression adversely affects quality of life in COPD patients, associated with higher rate of exacerbations, admissions and mortality. However, local prevalence rate of depression in geriatric COPD patients remains unknown.
Though BODE index is superior to FEV1 in prediction of depression in COPD, it is unclear which domain of BODE correlates best with depression. Furthermore, with multiple confounding factors, it's ambiguous that whether frequent exacerbation is an 'independent' predictor for depression among COPD patients.
The objective of this study is i.) to study the local prevalence rate of depression in geriatric COPD patients, ii.) to identify risk factors for depression especially looking at the any independent relationship between frequent exacerbations, various domains of BODE index and depression.
Detailed description
This study is a multi-centers, cross-sectional study, conducted in Kwong Wah Hospital and Wong Tai Sin Hospital, Hong Kong SAR. Age and comorbidity-matched COPD and control subjects were recruited from clinics. Depressive symptoms were measured by a validated Chinese version of Geriatric Depression Scale short form (GDS - 15 items) with 2 cut-off points. A score of 8 or above was considered significant depressive symptoms while the cut off score of 5 or above was for patients with mild depressive symptoms. Prevalence rates of depressive symptoms were measured in both COPD and control groups. Predictors for depression (GDS = or> 8) were determined using univariate and multivariate analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Other: Rate of depressionSpirometry confirmed COPD patients |
| Control | – | Other: Rate of depressionnormal geriatric patients without lung disease |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with spirometry confirmed airflow limitation
Key inclusion criteria (3 listed)
- aged 60 or above,
- with stable COPD suggested clinically and
- post-bronchodilator spirometry FEV1/FVC ratio <0.7.
Key exclusion criteria (2 listed)
- Patients were excluded if they had co-existing pulmonary diseases like active pulmonary tuberculosis, interstitial lung diseases etc;
- if they were too demented or physically incapacitated to participate e.g wheelchair-bound for bedbound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rate of depression | Other | COPD, Control |
Primary outcome
Prevalence of depression (Prevalence rate)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and COPD, run by Kwong Wah Hospital.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of depression (Prevalence rate) (time frame: 1 year). 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 14 Apr 2015.