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

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00283855
First received: January 26, 2006
Last updated: July 9, 2009
Last verified: December 2008
  Purpose

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 Intervention
Rheumatoid Arthritis
Behavioral: Online self-management program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: An Online Self Management Program for Adults With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Primary outcomes will be measured at baseline, 3 months, six months, nine months and twelve months. [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos. ] [ Designated as safety issue: No ]
  • Arthritis Impact Measurement Scales [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos. ] [ Designated as safety issue: No ]
  • Arthritis Self-Efficacy Scale [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ] [ Designated as safety issue: No ]
  • Rapid Assessment of Disease Activity in Rheumatology [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ] [ Designated as safety issue: No ]
  • Physical Activity Scale for the Elderly [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ] [ Designated as safety issue: No ]
  • Center for Epidemiological Studies - Depression Scale [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ] [ Designated as safety issue: No ]
  • UCLA Loneliness Scale [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ] [ Designated as safety issue: No ]
  • 21-point Box Scale (a pain measure) [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ] [ Designated as safety issue: No ]
  • Social Provisions Scale [ Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2003
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Active Comparator: Online Self-Management Behavioral: Online self-management program
Customized web application offers secure, encrypted communication allowing private and community-wide exchange of information. Components include discussion board, chat room, messaging, online delivery of Stress-Management sessions (online reading material and "homework assignments"). Completion of SM sessions followed by telephone call from study staff to address participant questions, reinforce cognitive-behavioral principles, provide ongoing encouragement and direction to engage in the community and complete homework assignments.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen L. Smarr, PhD, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00283855     History of Changes
Other Study ID Numbers: H133B031120-Proj 1
Study First Received: January 26, 2006
Last Updated: July 9, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014