NCT01357018

Brief Summary

Chronic joint complaints are prevalent in clinical practice. If chronic arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis (AS) is not adequately controlled, it can not only affect patient's working ability but also produce indirect cost in patient's family. Quality of life will also be affected. Health-related quality of life issues are assuming increasing importance in chronic rheumatic diseases. However, studies on quality of life in rheumatic patients are limited. Factors related to quality of life are not clear. Application of quality of life measurement for improving clinical care of RA and AS patients is still difficult. The objective of this study was to evaluation the validity of EQ-5D life quality measurement in chronic arthritis patients in Taiwan. Factors associated with life quality will be addressed. This will also provide useful information for public health policy making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

2.1 years

First QC Date

December 7, 2010

Last Update Submit

February 19, 2014

Conditions

Keywords

Ankylosing spondylitisDisease activityEQ-5DQuality of lifeRheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • Validity of life quality measurement EQ-5D in chronic arthritis patients

    Effect of age, gender, diagnosis, disease duration and education on subjective feeling of quality of life (by EQ-5D) will be analyzed. Repeated measurements will be used for analysis of association between disease activity and quality of life.

    EQ-5D at recruitment and 6 months later in chronic arthritis patients

Study Arms (2)

patients with rheumatoid arthritis

patients with ankylosing spondylitis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with rheumatoid arthritis or ankylosing spondylitis

You may qualify if:

  • Patients with rheumatoid arthritis or ankylosing spondylitis

You may not qualify if:

  • Patients with mental illness which interfered with questionaire answering

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei County, 220, Taiwan

Location

MeSH Terms

Conditions

Spondylitis, AnkylosingArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Chien-Sheng Wu

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Rheumatology

Study Record Dates

First Submitted

December 7, 2010

First Posted

May 20, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations