NCT00747578

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
Last Updated

September 8, 2008

Status Verified

September 1, 2008

First QC Date

September 4, 2008

Last Update Submit

September 5, 2008

Conditions

Keywords

ankylosing spondylitis (AS), costs,rheumatoid arthritis (RA),systemic lupus erythematosus (SLE),health-relatedquality of life (HRQOL)compareutilitypatients

Study Arms (3)

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 Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • \. Patients who have cognitive impairment.
  • \. Patients who have overlapping syndrome of any 2 of the 3 rheumatic disease (eg. RA overlapping with SLE).
  • \. Patients who are less than 18 years old or older than 65 years old.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidLupus Erythematosus, SystemicSpondylitis, Ankylosing

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosis

Central Study Contacts

Hsin-Hua Chen, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 5, 2008

Study Start

September 1, 2008

Last Updated

September 8, 2008

Record last verified: 2008-09

Locations