Fatigue in Rheumatoid Arthritis - Longitudinal Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01697202
First received: August 29, 2012
Last updated: February 19, 2014
Last verified: February 2014
  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 ] [ Designated as safety issue: No ]
    patient administered questionnaire


Secondary Outcome Measures:
  • Pain [ Time Frame: 4 times during the course of the study up to one year ] [ Designated as safety issue: No ]
    patient administered questionnaire

  • Activity limitations [ Time Frame: 4 times during the course of the study up to one year ] [ Designated as safety issue: No ]
    patient administered questionnaire

  • Disease activity [ Time Frame: 4 times during the course of the study up to one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697202

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

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01697202     History of Changes
Other Study ID Numbers: GoteborgU
Study First Received: August 29, 2012
Last Updated: February 19, 2014
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014