Rheumatoid ArthritisNCT00000414
Patient Education in Rheumatoid Arthritis and Osteoarthritis
A study testing Arthritis Self-Management Program and SMART Program in people with Rheumatoid Arthritis and Osteoarthritis, run by Stanford University at 5 sites in 2 countries.
Trial summary
This project will evaluate the effectiveness and general usefulness of two arthritis patient education programs. The first, the Arthritis Self-Management Program, is a 6-week, community-based program taught in small groups by peer leaders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis
- What is being tested?
- Arthritis Self-Management Program and SMART Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 1996to Apr 2001
- 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
- Physician diagnosis of OA or RA
- Participation in the ARAMIS longitudinal study
Who cannot join
- Age under 18
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Vanderbilt University
Nashville, Tennessee
Stanford University
Palo Alto, California, 94305
University of Pittsburgh
Pittsburgh, Pennsylvania
Wichita Arthritis Center
Wichita, Kansas
About this study
Official title: Patient Education Strategies for Better Outcomes in Rheumatoid Arthritis (RA) and Osteoarthritis (OA)
This project will evaluate the effectiveness and general usefulness of two arthritis patient education programs. The first, the Arthritis Self-Management Program, is a 6-week, community-based program taught in small groups by peer leaders. The second, the Self-Managed Arthritis Relief Therapy (SMART) Program, is a computer-driven program delivered through the mail. Participants in this project are people with rheumatoid arthritis or osteoarthritis who are taking part in the larger long-term studies being conducted by ARAMIS (the Arthritis, Rheumatism and Aging Medical Information System).
Read the detailed description
In a changing health care environment, the role of patients in managing their arthritis is increasingly important. Patient education is the primary means for teaching patients how to fulfill this role successfully. The goal of self-management health education is not merely to provide information but also to change patient attitudes and behavior so that patient outcomes are improved. These programs represent a new treatment for arthritis.
This project will evaluate the relative effect on health status and cost-effectiveness of two arthritis patient education programs that use different delivery systems. The Arthritis Self-Management Program (ASMP) uses a small group, multi-class format. It is taught by trained lay leaders and has been evaluated for effectiveness and widely disseminated. The Self-Managed Arthritis Relief Therapy (SMART) Program is a computer-driven, individualized, mail-delivered intervention. Results of a pilot study suggest that it is effective in improving health status and reducing health care use.
The project will also evaluate how generalizable the SMART program is and its effectiveness for patients with different diagnoses (OA and RA). It will also determine the attributes of patients who choose and do not choose to participate in patient education programs as well as the attributes of those who complete and do not complete the ASMP and SMART programs.
Through use of the ARAMIS data collection system, the project allows us to describe the differences between people who volunteer to receive patient education and those who refuse patient education. This project is directed at improving patient outcomes in both RA and OA through wide availability of a low-cost, mail-delivered arthritis self-management program that is the next generation in arthritis health education.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Being tested
- Arthritis Self-Management Program, SMART Program
- Keywords
- Rheumatoid arthritis (RA), Osteoarthritis (OA), Arthritis education, Health care service evaluation, Outcomes research, Arthritis Self-Management Program (ASMP), Self-Managed Arthritis Relief Therapy (SMART) Program
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthritis Self-Management ProgramBehavioural
SMART ProgramBehavioural
Also called Self-Managed Arthritis Relief Therapy (SMART)
| Study group | Role | What they receive |
|---|---|---|
| Arthritis Self-Management Program | Experimental | small group self-management program Receives: Behavioral: Arthritis Self-Management Program |
| SMART Program | Experimental | Self-Managed Arthritis Relief Therapy: mailed self management material Receives: Behavioral: SMART Program |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 1996
- Primary completionApr 2001
- Study completionApr 2001
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 Rheumatoid ArthritisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Kate Lorig, Stanford University
- Investigators
- Kate R. Lorig, DrPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000414
- Sponsor's protocol ID
- P01 AR43584 Substudy 004
- Other IDs
- P01AR043584
- Status last verified
- Nov 2004
- First submitted
- 3 Nov 1999
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lorig KR, Ritter PL, Laurent DD, Fries JF. Long-term randomized controlled trials of tailored-print and small-group arthritis self-management interventions. Med Care. 2004 Apr;42(4):346-54. doi: 10.1097/01.mlr.0000118709.74348.65.
PubMed 15076811
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education Strategies for Better Outcomes in Rheumatoid Arthritis (RA) and Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT00000414
- Acronym / sponsor ID
- P01 AR43584 Substudy 004
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Keywords
- Rheumatoid arthritis (RA), Osteoarthritis (OA), Arthritis education, Health care service evaluation, Outcomes research, Arthritis Self-Management Program (ASMP), Self-Managed Arthritis Relief Therapy (SMART) Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jul 1996
- Primary completion
- Apr 2001 (actual)
- Study completion
- Apr 2001 (actual)
- First posted
- 4 Nov 1999 (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.
This project will evaluate the effectiveness and general usefulness of two arthritis patient education programs. The first, the Arthritis Self-Management Program, is a 6-week, community-based program taught in small groups by peer leaders. The second, the Self-Managed Arthritis Relief Therapy (SMART) Program, is a computer-driven program delivered through the mail. Participants in this project are people with rheumatoid arthritis or osteoarthritis who are taking part in the larger long-term studies being conducted by ARAMIS (the Arthritis, Rheumatism and Aging Medical Information System).
Detailed description
In a changing health care environment, the role of patients in managing their arthritis is increasingly important. Patient education is the primary means for teaching patients how to fulfill this role successfully. The goal of self-management health education is not merely to provide information but also to change patient attitudes and behavior so that patient outcomes are improved. These programs represent a new treatment for arthritis.
This project will evaluate the relative effect on health status and cost-effectiveness of two arthritis patient education programs that use different delivery systems. The Arthritis Self-Management Program (ASMP) uses a small group, multi-class format. It is taught by trained lay leaders and has been evaluated for effectiveness and widely disseminated. The Self-Managed Arthritis Relief Therapy (SMART) Program is a computer-driven, individualized, mail-delivered intervention. Results of a pilot study suggest that it is effective in improving health status and reducing health care use.
The project will also evaluate how generalizable the SMART program is and its effectiveness for patients with different diagnoses (OA and RA). It will also determine the attributes of patients who choose and do not choose to participate in patient education programs as well as the attributes of those who complete and do not complete the ASMP and SMART programs.
Through use of the ARAMIS data collection system, the project allows us to describe the differences between people who volunteer to receive patient education and those who refuse patient education. This project is directed at improving patient outcomes in both RA and OA through wide availability of a low-cost, mail-delivered arthritis self-management program that is the next generation in arthritis health education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthritis Self-Management Program | Experimental | Behavioral: Arthritis Self-Management Programsmall group self-management program |
| SMART Program | Experimental | Behavioral: SMART ProgramSelf-Managed Arthritis Relief Therapy: mailed self management material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician diagnosis of OA or RA
- Participation in the ARAMIS longitudinal study
Key exclusion criteria (1 listed)
- Age under 18
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 |
|---|---|---|
| Arthritis Self-Management Program | Behavioural | Arthritis Self-Management Program |
| SMART ProgramAlso: Self-Managed Arthritis Relief Therapy (SMART) | Behavioural | SMART Program |
Primary outcome
Not reported in the source record.
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 21 Jun 2013.
- Background: PubMed 15076811Lorig KR, Ritter PL, Laurent DD, Fries JF. Long-term randomized controlled trials of tailored-print and small-group arthritis self-management interventions. Med Care. 2004 Apr;42(4):346-54. doi: 10.1097/01.mlr.0000118709.74348.65.
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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 University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthritis Self-Management Program and SMART Program in people with Rheumatoid Arthritis and Osteoarthritis, run by Stanford University at 5 sites in 2 countries.
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 1 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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000414, 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 21 Jun 2013.