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

September 29, 2016 updated by: University of Missouri-Columbia

An Online Self Management Program for Adults With Rheumatoid Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arthritis Impact Measurement Scales
Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos.
baseline, 3 mos., 6 mos., 9 mos., 12 mos.

Secondary Outcome Measures

Outcome Measure
Time Frame
Arthritis Self-Efficacy Scale
Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos
baseline, 3 mos., 6 mos., 9 mos., 12 mos
Rapid Assessment of Disease Activity in Rheumatology
Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos
baseline, 3 mos., 6 mos., 9 mos., 12 mos

Other Outcome Measures

Outcome Measure
Time Frame
Social Provisions Scale
Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos
baseline, 3 mos., 6 mos., 9 mos., 12 mos
21-point Box Scale (a pain measure)
Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos
baseline, 3 mos., 6 mos., 9 mos., 12 mos
UCLA Loneliness Scale
Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos
baseline, 3 mos., 6 mos., 9 mos., 12 mos
Center for Epidemiological Studies - Depression Scale
Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos
baseline, 3 mos., 6 mos., 9 mos., 12 mos
Physical Activity Scale for the Elderly
Time Frame: baseline, 3 mos., 6 mos., 9 mos., 12 mos
baseline, 3 mos., 6 mos., 9 mos., 12 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Collaborators

U.S. Department of Education

Investigators

  • Principal Investigator: Karen L Smarr, Ph.D., University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 30, 2006

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H133B031120-Proj 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe