ArthritisNCT00207623
Evaluation of the Arthritis Basics for Change (ABCs) Self Management Program
A study testing Arthritis Basics for Change Education program in people with Arthritis, run by Centers for Disease Control and Prevention.
Trial summary
While there are a variety of arthritis education materials available, the evidence-base on most of them is slim, so it i impossible to know what benefits they may have for the people who participate. 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 Basics for Change Education program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Jul 2003
- 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
- adults with arthritis
Who cannot join
- -
About this study
While there are a variety of arthritis education materials available, the evidence-base on most of them is slim, so it i impossible to know what benefits they may have for the people who participate. The purpose of this project is to evaluate the effectiveness of the mail-delivered self-management education program, Arthritis Basics for Change (ABCS) with an emphasis on changes in knowledge, beliefs, behavior, self efficacy and health outcomes, and to evaluate the appropriateness, usefulness, and readibility of the program. This project will assist CDC's Arthritis Program in determining the usefulness of the ABCs program for helping people with arthritis improve their quality of life.
- Conditions
- Arthritis
- Being tested
- Arthritis Basics for Change Education program
- Keywords
- arthritis, self management, patient education
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthritis Basics for Change Education programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthritis management knowledge at 6 months
self management beliefs at 6 months
Self management behaviors at 6 months
Self efficacy for arthritis management at 6 months
Health status at 6 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 startJul 2002
- Study completionJul 2003
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
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- St. Louis University
- Investigators
- Anjali D Despande, PhD, MPH, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207623
- Sponsor's protocol ID
- CDC-NCCDPHP-SIP 3-01
- Other IDs
- U88/CCU715766-SIP 3-01
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Arthritis Basics for Change (ABCs) Self Management Program
- ClinicalTrials.gov ID
- NCT00207623
- Acronym / sponsor ID
- CDC-NCCDPHP-SIP 3-01
- Conditions
- Arthritis
- Keywords
- arthritis, self management, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- St. Louis University
- Study start
- Jul 2002
- Study completion
- Jul 2003
- 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.
While there are a variety of arthritis education materials available, the evidence-base on most of them is slim, so it i impossible to know what benefits they may have for the people who participate. The purpose of this project is to evaluate the effectiveness of the mail-delivered self-management education program, Arthritis Basics for Change (ABCS) with an emphasis on changes in knowledge, beliefs, behavior, self efficacy and health outcomes, and to evaluate the appropriateness, usefulness, and readibility of the program. This project will assist CDC's Arthritis Program in determining the usefulness of the ABCs program for helping people with arthritis improve their quality of life.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 Basics for Change Education program | Behavioural | – |
Primary outcome
Arthritis management knowledge at 6 months
self management beliefs at 6 months
Self management behaviors at 6 months
Self efficacy for arthritis management at 6 months
Health status at 6 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 21 Sep 2005.
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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.
Anjali D Despande, PhD, MPH principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
A study testing Arthritis Basics for Change Education program in people with Arthritis, run by Centers for Disease Control and Prevention.
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 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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?
Arthritis management knowledge at 6 months. 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?
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 Sep 2005.