Clinical trial NCT00398255: Healthier Living With Arthritis Online Program
Official title: Internet Arthritis Self-Management Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Fibromyalgia
Keywords: arthritis
self management
patient education
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-11-10
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Distress Scale at six months and one year
measure: Activities Limitation Scale at six months and one year
measure: Self Efficacy for Management of Arthritis Scale at six months and one year
measure: Stretching and strengthening exercise at six months and one year
measure: Visits of Physicians at six months and one year
Secondary outcomes:
measure: Self-Reported General Health at six months and one year
measure: Visual Numeric Pain at six months and one year
measure: Visual Numeric Fatigue at six months and one year
measure: Disability at six months and one year
measure: Aerobic Exercise at six months and one year
measure: Communication with Physician at six months and one year
measure: Cognitive Sympton Management at six months and one year
measure: Emergency Department Visits at six months and one year
measure: Nights in Hospital at six months and one year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine Patient Education Center
state: California
Study officials:
affiliation: Stanford School of Medicine
name: Kate R. Lorig, DrPh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lorig KR, Ritter PL, Laurent DD, Plant K. The internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Arthritis Rheum. 2008 Jul 15;59(7):1009-17. doi: 10.1002/art.23817.