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Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT00747578
First received: September 4, 2008
Last updated: September 5, 2008
Last verified: September 2008

September 4, 2008
September 5, 2008
September 2008
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Complete list of historical versions of study NCT00747578 on ClinicalTrials.gov Archive Site
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Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan
Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan

Ankylosing spondylitis (AS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) are the most common rheumatic diseases dealt with rheumatologists in Taiwan. In previous studies, the 3 diseases all have broad impacts on health-related quality of life of patients and drive enormous economic burden on patients and society. The objective of this study is to compare health-related quality of life and disease-related costs between patients with the 3 different diseases.

We will invite at least 100 patients with AS, RA or SLE respectively who are regularly followed in the outpatient clinic of the Division of Rheumatology at Taichung Veterans General Hospital (VGHTC) to participate in the study. Patients who have cognitive impairment, who are older than 65 years old or younger than 18 years old, who have overlapping syndrome of any 2 of the 3 rheumatic diseases (eg. RA overlapping with SLE) or who have visited rheumatologists in the outpatient clinics at VGHTC for less than 4 times in 2008 will be excluded. Patients who agree to take part will attend a comprehensive clinical examination in the outpatient department. Patients will complete a questionaire including demographic and disease characteristics, and health-related quality of life at the time of survey. The questionaires about disease-related costs will be completed once per quarter throughout 2009. The four questionaires about costs will be given at the time of initial survey and will be returned by returned by mail or in the following outpatient clinics visits every 3 months in 2009.

The result of this study will help patients to realize their own health-related quality of life and disease-related costs and help government in Taiwan to realize the socioeconomic burden of the 3 common rheumatic diseases and to allocate health care resources more properly in the future.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

We will invite at least 100 patients with AS who fit the modified New York criteria (1984) [19] , at least 100 patients with RA who fit the American College of Rheumatology (ACR) criteria (1987) [20] and at least 100 patients with SLE who fit the ACR revised criteria for the classification of SLE (1997) [21] in the outpatient clinics of the Division of Rheumatology at Taichung Veterans General Hospital to participate in the study.

  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Ankylosing Spondylitis
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  • 1

    AS patients who fit the modified New York criteria (1984)

    Exclusion criteria :

    1. Patients who have cognitive impairment.
    2. Patients who have overlapping syndrome of any 2 of the 3 rheumatic disease (eg. RA overlapping with SLE).
    3. Patients who are less than 18 years old or older than 65 years old.
    4. Patients who visited rheumatologists in the outpatient clinics of the Division of Rheumatology at Taichung Veterans General Hospital for less than 4 times in 2008.
  • 2

    RA patients who fit the American College of Rheumatology (ACR) criteria (1987)

    Exclusion criteria :

    1. Patients who have cognitive impairment.
    2. Patients who have overlapping syndrome of any 2 of the 3 rheumatic disease (eg. RA overlapping with SLE).
    3. Patients who are less than 18 years old or older than 65 years old.
    4. Patients who visited rheumatologists in the outpatient clinics of the Division of Rheumatology at Taichung Veterans General Hospital for less than 4 times in 2008.
  • 3

    SLE patients who fit the ACR revised criteria for the classification of SLE (1997)

    Exclusion criteria :

    1. Patients who have cognitive impairment.
    2. Patients who have overlapping syndrome of any 2 of the 3 rheumatic disease (eg. RA overlapping with SLE).
    3. Patients who are less than 18 years old or older than 65 years old.
    4. Patients who visited rheumatologists in the outpatient clinics of the Division of Rheumatology at Taichung Veterans General Hospital for less than 4 times in 2008.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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Inclusion Criteria:

  • AS patients who fit the modified New York criteria (1984)
  • RA patients who fit the American College of Rheumatology (ACR) criteria (1987)
  • SLE patients who fit the ACR revised criteria for the classification of SLE (1997)

Exclusion Criteria:

  • 1. Patients who have cognitive impairment.
  • 2. Patients who have overlapping syndrome of any 2 of the 3 rheumatic disease (eg. RA overlapping with SLE).
  • 3. Patients who are less than 18 years old or older than 65 years old.
  • 4. Patients who visited rheumatologists in the outpatient clinics of the Division of Rheumatology at Taichung Veterans General Hospital for less than 4 times in 2008.
Both
18 Years to 65 Years
No
Contact: Hsin-Hua Chen, M.D. 886-4-23592525 ext 3336 shc5555@hotmail.com
Taiwan
 
NCT00747578
C08129
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The Institutional Review Board of Taichung Veterans General Hospital, Taichung Veterans General Hospital
Taichung Veterans General Hospital
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Taichung Veterans General Hospital
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP