Healthier Living With Arthritis Online Program

Rheumatoid Arthritis Clinical Trial

Official title:

Internet Arthritis Self-Management Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398255
• Other study ID #: NIH-AR43538
• Status: Completed
• Phase: N/A
• First received: November 9, 2006
• Last updated: April 29, 2013
• Start date: February 2004
• Est. completion date: December 2006

Study information

• Verified date: April 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.

Description:

An internet-based arthritis self-management program was developed based on the widely used small-group arthritis self-management program. Individuals with arthritis were recruited via established websites, on-line newsletters, discussion groups, calendar announcements and articles in newspapers, and asked to go to the project website. Subjects who filled out an informed consent and met all of the following criteria were invited to enroll:

1. At least 18 years of age

2. A physician's diagnosis of osteoarthritis, rheumatoid arthritis or fibromyalgia.

3. Not have been in active treatment for cancer for one year.

4. Not participated in the small group Arthritis Self-Management or Chronic Disease Self-Management Program

Those eligible and wishing to continue were randomized to receive the internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). On-line questionnaires were administered at baseline, six months and twelve months after the program. Measures included health indicators, health behaviors, self efficacy and health care utilization. It is hypothesized that course participants, compared to the usual-care control group, will show statistically significant improvements (using Analyses of Covariance and Logistic Regressions) in outcome variables and that the improvements will be associated with increased self-efficacy for management of arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• arthritic condition (osteoarthritis, rheumatoid arthritis or fibromyalgia)

• internet access and ability to use computer

Exclusion Criteria:

• active treatment for cancer

• taken small group arthritis self-management program

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Fibromyalgia
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Behavioral:
• self-management program

Locations

Country	Name	City	State
United States	Stanford University School of Medicine Patient Education Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Distress Scale at six months and one year
Primary	Activities Limitation Scale at six months and one year
Primary	Self Efficacy for Management of Arthritis Scale at six months and one year
Primary	Stretching and strengthening exercise at six months and one year
Primary	Visits of Physicians at six months and one year
Secondary	Self-Reported General Health at six months and one year
Secondary	Visual Numeric Pain at six months and one year
Secondary	Visual Numeric Fatigue at six months and one year
Secondary	Disability at six months and one year
Secondary	Aerobic Exercise at six months and one year
Secondary	Communication with Physician at six months and one year
Secondary	Cognitive Sympton Management at six months and one year
Secondary	Emergency Department Visits at six months and one year
Secondary	Nights in Hospital at six months and one year

External Links

•   Main webpage for center