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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00283855
Other study ID # H133B031120-Proj 1
Secondary ID
Status Completed
Phase N/A
First received January 26, 2006
Last updated September 29, 2016
Start date October 2003
Est. completion date September 2008

Study information

Verified date September 2016
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Online Self-Management
Online Self-Management

Locations

Country Name City State
United States University of Missouri-Columbia Columbia Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of Missouri-Columbia U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Other Social Provisions Scale baseline, 3 mos., 6 mos., 9 mos., 12 mos No
Other 21-point Box Scale (a pain measure) baseline, 3 mos., 6 mos., 9 mos., 12 mos No
Other UCLA Loneliness Scale baseline, 3 mos., 6 mos., 9 mos., 12 mos No
Other Center for Epidemiological Studies - Depression Scale baseline, 3 mos., 6 mos., 9 mos., 12 mos No
Other Physical Activity Scale for the Elderly baseline, 3 mos., 6 mos., 9 mos., 12 mos No
Primary Arthritis Impact Measurement Scales baseline, 3 mos., 6 mos., 9 mos., 12 mos. No
Secondary Arthritis Self-Efficacy Scale baseline, 3 mos., 6 mos., 9 mos., 12 mos No
Secondary Rapid Assessment of Disease Activity in Rheumatology baseline, 3 mos., 6 mos., 9 mos., 12 mos No
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