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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
  Purpose

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.


Condition
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Estimated Enrollment: 300
Study Start Date: September 2008
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747578

Contacts
Contact: Hsin-Hua Chen, M.D. 886-4-23592525 ext 3336 shc5555@hotmail.com

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Hsin-Hua Chen, M.D.    886-4-23592525 ext 3336    shc5555@hotmail.com   
Sponsors and Collaborators
Taichung Veterans General Hospital
  More Information

No publications provided

Responsible Party: The Institutional Review Board of Taichung Veterans General Hospital, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00747578     History of Changes
Other Study ID Numbers: C08129
Study First Received: September 4, 2008
Last Updated: September 5, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
ankylosing spondylitis (AS), costs,
rheumatoid arthritis (RA),
systemic lupus erythematosus (SLE),
health-related
quality of life (HRQOL)
compare
utility
patients

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies

ClinicalTrials.gov processed this record on November 24, 2014