Rheumatoid and OsteoarthritisPhase 2/3NCT00164489
Health Promotion of People With Disabilities
A Phase 2/3 study of Rheumatoid and Osteoarthritis, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
This research is meant to evaluate the effectiveness of two different prevention programs for post-acute management of rheumatoid and osteo-arthritis Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Rheumatoid and Osteoarthritis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jun 2005
- Phase
- Phase 2/3
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical visit 11/1/2003 to april 30/2004 diagnosis code rheumatoid arthritis or lower extremity osteoarthritis saw a provider that consented to have patients invited to participate consented to being contacted for research
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Institute
Minneapolis, Minnesota, 55416
About this study
Official title: Intervention Research Grants to Promote the Health of People With Disabilities
This research is meant to evaluate the effectiveness of two different prevention programs for post-acute management of rheumatoid and osteo-arthritis
Read the detailed description
Park Nicollet Clinic and the Institute for Clinical Systems Integration (ICSI) have developed evidence-based care guidelines and intervention strategies including degenerative joint disease. Included in these guidelines are risk factors for increased limitations, obesity and physical activity.
The aims of this research are to modify well-established weight management techniques and physical activity promotion interventions according to ICSI recommendations, implement the interventions in a diverse patient population, demonstrate the short and long term impact of the interventions.
The approach will be an individual randomized controlled trial of 400 patients, 200 each in a coach-supported intervention, 200 in a self-directed intervention.
- Conditions
- Rheumatoid and Osteoarthritis
- Being tested
- Weight control and physical activity promotion
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight control and physical activity promotionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
height weight: BMI
Healthy physical activity levels: 20 minutes of physical activity 4+ days/week
Secondary outcomes (4)
improved weight status
improved diet
decreased pain
reduced depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid and OsteoarthritisStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Barbara Braun, Ph.D., Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164489
- Sponsor's protocol ID
- CDC-NCBDDD-CCR523273
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2005
- Last updated
- 8 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Research Grants to Promote the Health of People With Disabilities
- ClinicalTrials.gov ID
- NCT00164489
- Acronym / sponsor ID
- CDC-NCBDDD-CCR523273
- Conditions
- Rheumatoid and Osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Oct 2003
- Study completion
- Jun 2005
- First posted
- 14 Sep 2005 (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 research is meant to evaluate the effectiveness of two different prevention programs for post-acute management of rheumatoid and osteo-arthritis
Detailed description
Park Nicollet Clinic and the Institute for Clinical Systems Integration (ICSI) have developed evidence-based care guidelines and intervention strategies including degenerative joint disease. Included in these guidelines are risk factors for increased limitations, obesity and physical activity.
The aims of this research are to modify well-established weight management techniques and physical activity promotion interventions according to ICSI recommendations, implement the interventions in a diverse patient population, demonstrate the short and long term impact of the interventions.
The approach will be an individual randomized controlled trial of 400 patients, 200 each in a coach-supported intervention, 200 in a self-directed intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical visit 11/1/2003 to april 30/2004 diagnosis code rheumatoid arthritis or lower extremity osteoarthritis saw a provider that consented to have patients invited to participate consented to being contacted for research
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Weight control and physical activity promotion | Behavioural | – |
Primary outcome
height weight: BMI
Healthy physical activity levels: 20 minutes of physical activity 4+ days/week
4 secondary outcomes
improved weight status
improved diet
decreased pain
reduced depression
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 8 Oct 2024.
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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.
Barbara Braun, Ph.D. principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study of Rheumatoid and Osteoarthritis, run by Centers for Disease Control and Prevention 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 1 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 8 Oct 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
height weight: BMI. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.