NCT00283855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

4.8 years

First QC Date

January 26, 2006

Last Update Submit

September 29, 2016

Conditions

Keywords

Rheumatoid ArthritisSelf-ManagementInternet

Outcome Measures

Primary Outcomes (1)

  • Arthritis Impact Measurement Scales

    baseline, 3 mos., 6 mos., 9 mos., 12 mos.

Secondary Outcomes (2)

  • Arthritis Self-Efficacy Scale

    baseline, 3 mos., 6 mos., 9 mos., 12 mos

  • Rapid Assessment of Disease Activity in Rheumatology

    baseline, 3 mos., 6 mos., 9 mos., 12 mos

Other Outcomes (5)

  • Social Provisions Scale

    baseline, 3 mos., 6 mos., 9 mos., 12 mos

  • 21-point Box Scale (a pain measure)

    baseline, 3 mos., 6 mos., 9 mos., 12 mos

  • UCLA Loneliness Scale

    baseline, 3 mos., 6 mos., 9 mos., 12 mos

  • +2 more other outcomes

Study Arms (2)

Control Group

NO INTERVENTION

No intervention

Online Self-Management

ACTIVE COMPARATOR

RAHelp.org

Behavioral: Online Self-Management

Interventions

Online Self-Management

Online Self-Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Related Publications (2)

  • 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

    BACKGROUND
  • Shigaki CL, Smarr KL, Siva C, Ge B, Musser D, Johnson R. RAHelp: an online intervention for individuals with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1573-81. doi: 10.1002/acr.22042.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Karen L Smarr, Ph.D.

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 30, 2006

Study Start

October 1, 2003

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations