Quality of Life in Chronic Arthritis | NCT01357018

Studies
Quality of Life in Chronic Arthritis

NCT01357018

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Feb 20, 2014Estimated

Enrollment

139Actual

Phase

Not provided

Conditions

Ankylosing Spondylitis
Rheumatoid Arthritis

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Apr 2013Actual

First Submitted Date

Dec 7, 2010

First Submission Date that Met QC Criteria

May 19, 2011

First Posted Date

May 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2014

Last Update Posted Date

Feb 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chien-Sheng Wu, Chief, Division of Rheumatology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

139Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with rheumatoid arthritis or ankylosing spondylitis

Exclusion Criteria:

Patients with mental illness which interfered with questionaire answering

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with rheumatoid arthritis or ankylosing spondylitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chien-Sheng Wu	Far Eastern Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		Taipei County		220	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D013167	Spondylitis, Ankylosing
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
patients with rheumatoid arthritis
patients with ankylosing spondylitis