OsteoarthritisNCT00398255
Healthier Living With Arthritis Online Program
A study testing self-management program in people with Osteoarthritis and Rheumatoid Arthritis, run by Stanford University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia
- What is being tested?
- self-management program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arthritic condition (osteoarthritis, rheumatoid arthritis or fibromyalgia)
- internet access and ability to use computer
Who cannot join
- active treatment for cancer
- taken small group arthritis self-management program
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine Patient Education Center
Palo Alto, California, 94305
About this study
Official title: Internet Arthritis Self-Management Study
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.
Read the 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:
- At least 18 years of age
- A physician's diagnosis of osteoarthritis, rheumatoid arthritis or fibromyalgia.
- Not have been in active treatment for cancer for one year.
- 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.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia
- Being tested
- self-management program
- Keywords
- arthritis, self management, patient education
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Fibromyalgia, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-management programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Distress Scale at six months and one year
Activities Limitation Scale at six months and one year
Self Efficacy for Management of Arthritis Scale at six months and one year
Stretching and strengthening exercise at six months and one year
Visits of Physicians at six months and one year
Secondary outcomes (9)
Self-Reported General Health at six months and one year
Visual Numeric Pain at six months and one year
Visual Numeric Fatigue at six months and one year
Disability at six months and one year
Aerobic Exercise at six months and one year
Communication with Physician at six months and one year
Cognitive Sympton Management at six months and one year
Emergency Department Visits at six months and one year
Nights in Hospital at six months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startFeb 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate R. Lorig, DrPh, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398255
- Sponsor's protocol ID
- NIH-AR43538
- Status last verified
- Apr 2013
- First submitted
- 9 Nov 2006
- Last updated
- 30 Apr 2013
- Results posted
- No
Publications
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.
PubMed 18576310
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Arthritis Self-Management Study
- ClinicalTrials.gov ID
- NCT00398255
- Acronym / sponsor ID
- NIH-AR43538
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia
- Keywords
- arthritis, self management, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 10 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- At least 18 years of age
- A physician's diagnosis of osteoarthritis, rheumatoid arthritis or fibromyalgia.
- Not have been in active treatment for cancer for one year.
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- arthritic condition (osteoarthritis, rheumatoid arthritis or fibromyalgia)
- internet access and ability to use computer
Key exclusion criteria (2 listed)
- active treatment for cancer
- taken small group arthritis self-management program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-management program | Behavioural | – |
Primary outcome
Health Distress Scale at six months and one year
Activities Limitation Scale at six months and one year
Self Efficacy for Management of Arthritis Scale at six months and one year
Stretching and strengthening exercise at six months and one year
Visits of Physicians at six months and one year
9 secondary outcomes
Self-Reported General Health at six months and one year
Visual Numeric Pain at six months and one year
Visual Numeric Fatigue at six months and one year
Disability at six months and one year
Aerobic Exercise at six months and one year
Communication with Physician at six months and one year
Cognitive Sympton Management at six months and one year
Emergency Department Visits at six months and one year
Nights in Hospital at six months and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Derived from this study: PubMed 18576310Lorig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate R. Lorig, DrPh principal investigator
Stanford School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-management program in people with Osteoarthritis and Rheumatoid Arthritis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Distress Scale at six months and one year. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00398255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.