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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00173797
Other study ID # 9361701232
Secondary ID NSC-94-2314-B-00
Status Recruiting
Phase N/A
First received September 13, 2005
Last updated September 13, 2005
Start date August 2005
Est. completion date April 2008

Study information

Verified date July 2005
Source National Taiwan University Hospital
Contact Ching-Lin Hsieh, PhD
Phone 886-2-23123456
Email clhsieh@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

This study is going to comprehensively examine the psychometric properties of the three depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.


Description:

This study is going to comprehensively examine the psychometric properties of the three depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.

This study will be divided into two parts. In the first part, we will spend 3 years in recruiting 200 consecutive patients with a diagnosis of first stroke onset to compare the validity, responsiveness, and acceptability of the HAMD, HADS, and BDI. All patients will be assessed using the three depression scales and other functional measures at 14, 30, 90, 180, and 365 days after stroke.

In the second part, the inter-rater reliability of the three depression scales will be examined in the first year. Sixty chronic stroke patients will be recruited in the study.

Furthermore, the other 60 chronic stroke patients will be recruited in the second year for examining the test-retest reliability and measurement error of the three depression scales.

This study would be the first one to systematically compare the psychometric properties of the three depression scales in a long-term follow up study. The results of the study will be able to help clinicians and researchers select the most suitable depression scales for stroke patients. The results will also provide us references to develop a new depression scale, if needed, for stroke patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

patients with a diagnosis stroke ability to complete questionnaires

Exclusion Criteria:

patients with other major diseases (e.g., cancer)

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan School of Occupational Therapy, College of Medicine, National Taiwan University Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

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