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Fatigue in Rheumatoid Arthritis - Longitudinal Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697202
First Posted: October 2, 2012
Last Update Posted: February 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Göteborg University
  Purpose
To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and which factors that may influence the fatigue.

Condition
Fatigue Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fatigue in Rheumatoid Arthritis - Longitudinal Study

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Fatigue [ Time Frame: 4 times during the course of the study up to one year ]
    patient administered questionnaire


Secondary Outcome Measures:
  • Pain [ Time Frame: 4 times during the course of the study up to one year ]
    patient administered questionnaire

  • Activity limitations [ Time Frame: 4 times during the course of the study up to one year ]
    patient administered questionnaire

  • Disease activity [ Time Frame: 4 times during the course of the study up to one year ]
    Tender and swollen joint count, patient-rated global health, inflammation parameters (DAS-28)

  • Health related quality of life [ Time Frame: 4 times during the course of the study upto one year ]
    patient administered questionnaire


Enrollment: 67
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
no intervention

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Persons with RA at the Rheumatology clinic at Sahlgrenska University hospital Gothenburg, Sweden
Criteria

Inclusion Criteria:

  • Diagnose of RA, age 20-65 years,

Exclusion Criteria:

  • other serious physical or mental illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697202


Locations
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden
Sponsors and Collaborators
Göteborg University
  More Information

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01697202     History of Changes
Other Study ID Numbers: GoteborgU
First Submitted: August 29, 2012
First Posted: October 2, 2012
Last Update Posted: February 20, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Fatigue
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms