ArthritisNCT00207441
Comparing ASHC and CDSMP Outcomes In Arthritis
A study testing Arthritis Self management program and Chronic Disease Self Management Program in people with Arthritis, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- Arthritis Self management program and Chronic Disease Self Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African american adults with arthritis Caucasian adults with arthritis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Craven County Health Department
New Bern, North Carolina, 28561
About this study
The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research studies is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural counties in North Carolina. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.
- Conditions
- Arthritis
- Being tested
- Arthritis Self management program, Chronic Disease Self Management Program
- Keywords
- arthritis, chronic disease, self management, self efficacy
- Medical subject headings
- Arthritis, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthritis Self management programBehavioural
Also called ASHC, AFSMP
Chronic Disease Self Management ProgramBehavioural
Also called Living Well with Chronic Conditions, Healthy Living
| Study group | Role | What they receive |
|---|---|---|
| Arthritis self management program | Experimental | Not described Receives: Behavioral: Arthritis Self management program |
| Chronic Disease Self Management Program | Experimental | Not described Receives: Behavioral: Chronic Disease Self Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life, measured at 4 and 12 months,
Measured: 4 months, 12 months
Health care utilization measured at 4 and 12 months
Measured: 4 months, 12 months
Secondary outcomes (2)
Self management behaviors measured at 4 and 12 months
Measured: 4 months, 12 months
Self efficacy for arthritis management, measured at 4 and 12 months
Measured: 4 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionOct 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of North Carolina, Chapel Hill, East Carolina University
- Investigators
- Jean Goeppinger, PhD RN, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207441
- Sponsor's protocol ID
- CDC-NCCDPHP-S2233-22/33
- Other IDs
- S2233-22/23
- Status last verified
- Mar 2011
- First submitted
- 13 Sep 2005
- Last updated
- 24 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing ASHC and CDSMP Outcomes In Arthritis
- ClinicalTrials.gov ID
- NCT00207441
- Acronym / sponsor ID
- CDC-NCCDPHP-S2233-22/33
- Conditions
- Arthritis
- Keywords
- arthritis, chronic disease, self management, self efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of North Carolina, Chapel Hill, East Carolina University
- Study start
- Apr 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 21 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.
The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research studies is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural counties in North Carolina. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.
Study design
- 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 program |
| Chronic Disease Self Management Program | Experimental | Behavioral: Chronic Disease Self Management Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African american adults with arthritis Caucasian adults with arthritis
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 |
|---|---|---|
| Arthritis Self management programAlso: ASHC, AFSMP | Behavioural | Arthritis self management program |
| Chronic Disease Self Management ProgramAlso: Living Well with Chronic Conditions, Healthy Living | Behavioural | Chronic Disease Self Management Program |
Primary outcome
Health related quality of life, measured at 4 and 12 months,
Time frame: 4 months, 12 months
Health care utilization measured at 4 and 12 months
Time frame: 4 months, 12 months
2 secondary outcomes
Self management behaviors measured at 4 and 12 months
Time frame: 4 months, 12 months
Self efficacy for arthritis management, measured at 4 and 12 months
Time frame: 4 months, 12 months
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 24 Mar 2011.
Related trials for Arthritis
Not yet recruitingObservational study
Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.
Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS)
Not yet recruitingPhase 2
PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
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.
Jean Goeppinger, PhD RN principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthritis Self management program and Chronic Disease Self Management Program in people with Arthritis, 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 24 Mar 2011. 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 related quality of life, measured at 4 and 12 months, (time frame: 4 months, 12 months). 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 24 Mar 2011.