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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02415140
Other study ID # KW/EX-13-142 (70-02)
Secondary ID
Status Completed
Phase N/A
First received April 8, 2015
Last updated April 13, 2015
Start date October 2013

Study information

Verified date April 2015
Source Kwong Wah Hospital
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- aged 60 or above,

- with stable COPD suggested clinically and

- post-bronchodilator spirometry FEV1/FVC ratio <0.7.

Exclusion Criteria:

- 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Rate of depression


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kwong Wah Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of depression (Prevalence rate) 1 year No
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