ArthritisNCT00000396
Arthritis Patient Education for Urban African Americans
A study testing Patient self-care education in people with Arthritis, run by University of Michigan at 1 site in United States.
Trial summary
Research has shown that people with arthritis can improve their ability to cope with arthritis pain with the help of patient education programs, which teach people things they can do to help manage their disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Patient self-care education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Oct 2002
- 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
- Urban African Americans with arthritis
- 18 years or older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 49109-0201
About this study
Official title: Evaluating/Reinforcing Arthritis Patient Education for Urban African Americans
Research has shown that people with arthritis can improve their ability to cope with arthritis pain with the help of patient education programs, which teach people things they can do to help manage their disease. However, we do not know much about the effects of arthritis patient education programs on minorities, such as urban African Americans.
We will gather participants for this project through a faith-based community network. The project is made up of four studies that will provide information about culturally relevant ways of reaching urban African Americans with arthritis and providing patient education that addresses arthritis care needs of the African American community. This project will also provide information on the effectiveness of an arthritis self-help course for urban African Americans. We hope to better understand the differences among cultural groups and how these differences should affect the design of culturally appropriate patient education.
Read the detailed description
Clinical studies have shown that arthritis patient education interventions are an effective addition to medical treatment in improving patients' ability to cope with pain, thereby reducing perceived symptom severity, improving patients' ability to help themselves, and providing them with skills and strategies for dealing with limits on daily activities. We know little, however, about generalizing the effects of such programs to cultural minority groups, such as urban African Americans. We know even less about the longevity of any benefits of patient education or about effective reinforcement and maintenance techniques. To examine these issues, we will recruit participants for this project through a faith-based community network to pursue the following aims:
- Evaluate the impact of arthritis patient education on arthritis symptoms and pain levels, functional status, self-care knowledge and behaviors, self-efficacy, emotional status, and health care resource use through a randomized controlled trial (Study 1).
- Test the impact of focused reinforcement of the concepts in the Arthritis Self-Help Course (ASHC) over a 12-month period through a randomized controlled trial (Study 2).
- Examine the detailed educational dynamics of the ASHC, identify aspects of the course that are less effective with or relevant to African Americans, and identify modes of communication and presentation used in the course that require adaptation for an African American audience (Study 3).
- Assess the personal and cultural belief systems underlying African Americans' understanding of arthritis and their use of conventional and unconventional arthritis treatments (Study 4).
These studies will provide valuable information regarding culturally relevant methods of reaching urban African Americans with arthritis and providing patient education that addresses arthritis care needs of the African American community. This study will also clarify the longevity of educational benefits and the effectiveness of alternative methods of educational reinforcement in this population. The exploratory studies of individual beliefs and knowledge of arthritis and its treatment, and the formal evaluation of a patient education program, will provide a better understanding of the ways in which cultural groups differ and how these differences should influence the design and delivery of culturally appropriate patient education.
- Conditions
- Arthritis
- Being tested
- Patient self-care education
- Keywords
- Arthritis, Arthritis education, African Americans, Self-help, Self-management, Cultural beliefs
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient self-care educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Education in Arthritis Self-Help Course Receives: Behavioral: Patient self-care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of arthritis self-care behaviors
Measured: Measured upon completion of the educational intervention and at 6-month follow-up
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 startSep 1997
- Primary completionMar 2001
- Study completionOct 2002
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.
- More trials run by University of MichiganThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Larry Gruppen, University of Michigan
- Investigators
- Larry D. Gruppen, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000396
- Sponsor's protocol ID
- P60AR020557
- Other IDs
- P60AR020557, NIAMS-016
- Status last verified
- Jun 2013
- First submitted
- 3 Nov 1999
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating/Reinforcing Arthritis Patient Education for Urban African Americans
- ClinicalTrials.gov ID
- NCT00000396
- Acronym / sponsor ID
- P60AR020557
- Conditions
- Arthritis
- Keywords
- Arthritis, Arthritis education, African Americans, Self-help, Self-management, Cultural beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 1997
- Primary completion
- Mar 2001 (actual)
- Study completion
- Oct 2002 (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.
Research has shown that people with arthritis can improve their ability to cope with arthritis pain with the help of patient education programs, which teach people things they can do to help manage their disease. However, we do not know much about the effects of arthritis patient education programs on minorities, such as urban African Americans.
We will gather participants for this project through a faith-based community network. The project is made up of four studies that will provide information about culturally relevant ways of reaching urban African Americans with arthritis and providing patient education that addresses arthritis care needs of the African American community. This project will also provide information on the effectiveness of an arthritis self-help course for urban African Americans. We hope to better understand the differences among cultural groups and how these differences should affect the design of culturally appropriate patient education.
Detailed description
Clinical studies have shown that arthritis patient education interventions are an effective addition to medical treatment in improving patients' ability to cope with pain, thereby reducing perceived symptom severity, improving patients' ability to help themselves, and providing them with skills and strategies for dealing with limits on daily activities. We know little, however, about generalizing the effects of such programs to cultural minority groups, such as urban African Americans. We know even less about the longevity of any benefits of patient education or about effective reinforcement and maintenance techniques. To examine these issues, we will recruit participants for this project through a faith-based community network to pursue the following aims:
- Evaluate the impact of arthritis patient education on arthritis symptoms and pain levels, functional status, self-care knowledge and behaviors, self-efficacy, emotional status, and health care resource use through a randomized controlled trial (Study 1).
- Test the impact of focused reinforcement of the concepts in the Arthritis Self-Help Course (ASHC) over a 12-month period through a randomized controlled trial (Study 2).
- Examine the detailed educational dynamics of the ASHC, identify aspects of the course that are less effective with or relevant to African Americans, and identify modes of communication and presentation used in the course that require adaptation for an African American audience (Study 3).
- Assess the personal and cultural belief systems underlying African Americans' understanding of arthritis and their use of conventional and unconventional arthritis treatments (Study 4).
These studies will provide valuable information regarding culturally relevant methods of reaching urban African Americans with arthritis and providing patient education that addresses arthritis care needs of the African American community. This study will also clarify the longevity of educational benefits and the effectiveness of alternative methods of educational reinforcement in this population. The exploratory studies of individual beliefs and knowledge of arthritis and its treatment, and the formal evaluation of a patient education program, will provide a better understanding of the ways in which cultural groups differ and how these differences should influence the design and delivery of culturally appropriate patient education.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Patient self-care educationEducation in Arthritis Self-Help Course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Urban African Americans with arthritis
- 18 years or older
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Patient self-care education | Behavioural | 1 |
Primary outcome
Knowledge of arthritis self-care behaviors
Time frame: Measured upon completion of the educational intervention and at 6-month follow-up
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 11 Jun 2013.
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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.
Larry D. Gruppen, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient self-care education in people with Arthritis, run by University of Michigan 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 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 11 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 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?
Knowledge of arthritis self-care behaviors (time frame: Measured upon completion of the educational intervention and at 6-month follow-up). 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 11 Jun 2013.