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RAHelp.Org: An Online Self Management Program for Adults With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00283855
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to determine the effects of an arthritis self-management program and an online support community delivered via an encrypted, secure web site on psychological well-being, pain, quality of life, global health status, and social supporting in adults with RA.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Behavioral: Online Self-Management

Detailed Description:
Arthritis is the leading cause of disability in the United States. More than 7 million persons in this country report limitations in their daily activities due to arthritis. Rheumatoid arthritis alone affects 1 of every 100 persons in the US. Clinic-based self-management programs have been found to be effective in reducing both pain and disability for persons with RA. However, barriers to participation exist such as distance, time, limited transportation, and declining functional status. The Internet is widely used as a source of information about health issues and may provide an opportunity to reduce these barriers and extend consumer access to self-management approaches. It is necessary to determine the efficacy of Internet-delivered self-management programs.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: An Online Self Management Program for Adults With Rheumatoid Arthritis
Study Start Date : October 2003
Primary Completion Date : August 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control Group
No intervention
Active Comparator: Online Self-Management
RAHelp.org
Behavioral: Online Self-Management
Online Self-Management


Outcome Measures

Primary Outcome Measures :
  1. Arthritis Impact Measurement Scales [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos. ]

Secondary Outcome Measures :
  1. Arthritis Self-Efficacy Scale [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ]
  2. Rapid Assessment of Disease Activity in Rheumatology [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ]

Other Outcome Measures:
  1. Social Provisions Scale [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ]
  2. 21-point Box Scale (a pain measure) [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ]
  3. UCLA Loneliness Scale [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ]
  4. Center for Epidemiological Studies - Depression Scale [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ]
  5. Physical Activity Scale for the Elderly [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 or more years of age
  • Rheumatoid Arthritis diagnosed by a rheumatologist
  • Stable medication regimen for 3 months

Exclusion Criteria:

  • Previous exposure to arthritis self-management programs
  • Uncontrolled psychiatric comorbidity
  • Uncontrolled medical comorbidity (e.g. active cancer)
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): NCT00283855


Locations
United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
U.S. Department of Education
Investigators
Principal Investigator: Karen L Smarr, Ph.D. University of Missouri-Columbia
More Information

Publications:
Smarr K; Musser D; Donovan Hanson K; Laffey J; Johnson R; Siva C; Parker J. Development of an online self-management intervention for persons with rheumatoid arthritis: The RAHelp.org project. Arthritis Rheum 2005 Sep;52(9):S718

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00283855     History of Changes
Other Study ID Numbers: H133B031120-Proj 1
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
Rheumatoid Arthritis
Self-Management
Internet

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