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

NCT ID: NCT00747578

Last Updated: 2008-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis Systemic Lupus Erythematosus Ankylosing Spondylitis

Keywords

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ankylosing spondylitis (AS), costs, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), health-related quality of life (HRQOL) compare utility patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsin-Hua Chen, M.D.

Role: CONTACT

Phone: 886-4-23592525

Email: [email protected]

Facility Contacts

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Hsin-Hua Chen, M.D.

Role: primary

Other Identifiers

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C08129

Identifier Type: -

Identifier Source: org_study_id