Rheumatoid ArthritisNCT00069342
Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
An observational study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will explore the diverse health beliefs and behaviors among minority patients with rheumatic diseases. These diseases may cause joint pain, stiffness or swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune system-the body's defense against disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Arthritis
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2003to 12 Apr 2018
- Phase
- Observational
- 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
- Phase I and II Focus Groups and Cognitive Testing of Instruments:
- Previously enrolled patients with known or suspected rheumatic disease and participating in NIAMS protocol # 01-AR-0227 Natural History of Rheumatic Disease in Minority Communities Individuals identified as community leaders or members of the Community Health Partnership will also be included in the focus groups.
- Phase III Baseline and Follow-up Assessments:
- Newly enrolled patients (within 7 days of enrollment on protocol #01-AR-0227) with known or suspected rheumatic disease participating in NIAMS protocol # 01-AR-0227 Natural History of Rheumatic Disease in Minority Communities.
- Age greater than or equal to 18 years.
- Willingness and capacity to provide informed consent
Who cannot join
- Patients will be excluded if any of the inclusion criteria on the parent protocol # 01-AR-0227 cannot be met.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Health Beliefs and Health Behavior Practices Among Minorities With Rheumatic Diseases
This study will explore the diverse health beliefs and behaviors among minority patients with rheumatic diseases. These diseases may cause joint pain, stiffness or swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune system-the body's defense against disease. Some rheumatic diseases are painful or deforming and some can be life-threatening. Many rheumatic diseases occur more often and more severely in certain minority communities. This study will explore psychosocial and cultural factors related to rheumatic disease in minorities.
Patients enrolled in the NIAMS protocol Natural History or Rheumatic Disease in Minority Communities (protocol #01-AR-0227) may participate in this study. Participants will be evaluated at the NIAMS Community Health Center at the Upper Cardozo Health Center in Washington, D.C.
Read more
Participants will be interviewed about individual and community health behavior, and health beliefs about rheumatic disease and its effects on several areas of their life, including mood and physical activity. The interview will be in one of the following formats: 1) in-depth cognitive interview, 2) focus group, or 3) face-to-face interview, as follows:
In-Depth Cognitive Interview
Participants take part in a one-time interview conducted by one investigator, observed by another, and tape recorded. The interview lasts from 1 to 2 hours.
Focus Groups
Participants take part in a group interview of from 6 to 10 people during a one-time tape-recorded session that lasts from 2 to 2-1/2 hours. The group discussion is led by a moderator and a facilitator, who takes notes and makes observations.
Face-to Face Interview
Participants are interviewed twice - first upon enrollment at the NIAMS Community Health Center and again after 6 months' follow-up at the Center.
Read the detailed description
Rheumatic diseases are among the most common health problems in the United States. They are a diverse group of disorders, with several shared characteristics. Marked differences in the incidence, prevalence, severity, processes of care, and outcomes in a number of rheumatic conditions exist among racial and ethnic groups as compared to white Americans. Furthermore, access to health care and treatment also differs in the minority community as compared with the majority.
The effects of the disease may be modifiable by changes in life style, diet, activities and exercise. Such changes are difficult for patients to accomplish and various strategies have been developed to facilitate success. Strategies include educational materials and programs, diet and exercise programs, patient support and empowerment programs and the like. Differences in culture and environment, lack of culturally sensitive materials and approaches, and lack of trained personnel may make these tools ineffective in the minority community. Their effectiveness in the African-American or Latino clinic population has not been assessed to date.
This is a descriptive, exploratory study designed to examine the diverse health beliefs and behaviors among the minority patients who are enrolled in the NIAMS Natural History of Rheumatic Disease in Minority Communities protocol (# 01-AR-0227). Qualitative and quantitative methodology will be used to assess the psychosocial and cultural correlates of rheumatic diseases in newly enrolled patients both at intake and after six months of being followed at the NIAMS Community Health Center, an outreach site located in the District of Columbia in the Upper Cardozo Health Center.
- Keywords
- Chronic Pain, Pain, Rheumatoid Arthritis, Depression, Function, Rheumatic Disease
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Arthritis, Chronic Pain, Pain, Depression, Rheumatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: Cross- Sectional
Secondary outcomes (1)
functional Status -Stanford
Measured: Cross-Sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2003 (estimated)
- Study start22 Sep 2003
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gwenyth R Wallen, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069342
- Sponsor's protocol ID
- 030301
- Other IDs
- 03-CC-0301
- Status last verified
- 12 Apr 2018
- First submitted
- 23 Sep 2003
- Last updated
- 17 Apr 2018
- Results posted
- No
Publications
Wallen GR, Brooks AT. To Tell or Not to Tell: Shared Decision Making, CAM Use and Disclosure Among Underserved Patients with Rheumatic Diseases. Integr Med Insights. 2012;7:15-22. doi: 10.4137/IMI.S10333. Epub 2012 Oct 3.
PubMed 23071389Brooks AT, Andrade RE, Middleton KR, Wallen GR. Social support: a key variable for health promotion and chronic disease management in Hispanic patients with rheumatic diseases. Clin Med Insights Arthritis Musculoskelet Disord. 2014 Mar 16;7:21-6. doi: 10.4137/CMAMD.S13849. eCollection 2014.
PubMed 24701122
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Beliefs and Health Behavior Practices Among Minorities With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT00069342
- Acronym / sponsor ID
- 030301
- Keywords
- Chronic Pain, Pain, Rheumatoid Arthritis, Depression, Function, Rheumatic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 22 Sep 2003
- Study completion
- 12 Apr 2018
- First posted
- 24 Sep 2003 (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 study will explore the diverse health beliefs and behaviors among minority patients with rheumatic diseases. These diseases may cause joint pain, stiffness or swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune system-the body's defense against disease. Some rheumatic diseases are painful or deforming and some can be life-threatening. Many rheumatic diseases occur more often and more severely in certain minority communities. This study will explore psychosocial and cultural factors related to rheumatic disease in minorities.
Patients enrolled in the NIAMS protocol Natural History or Rheumatic Disease in Minority Communities (protocol #01-AR-0227) may participate in this study. Participants will be evaluated at the NIAMS Community Health Center at the Upper Cardozo Health Center in Washington, D.C.
Participants will be interviewed about individual and community health behavior, and health beliefs about rheumatic disease and its effects on several areas of their life, including mood and physical activity. The interview will be in one of the following formats: 1) in-depth cognitive interview, 2) focus group, or 3) face-to-face interview, as follows:
In-Depth Cognitive Interview
Participants take part in a one-time interview conducted by one investigator, observed by another, and tape recorded. The interview lasts from 1 to 2 hours.
Focus Groups
Participants take part in a group interview of from 6 to 10 people during a one-time tape-recorded session that lasts from 2 to 2-1/2 hours. The group discussion is led by a moderator and a facilitator, who takes notes and makes observations.
Face-to Face Interview
Participants are interviewed twice - first upon enrollment at the NIAMS Community Health Center and again after 6 months' follow-up at the Center.
Detailed description
Rheumatic diseases are among the most common health problems in the United States. They are a diverse group of disorders, with several shared characteristics. Marked differences in the incidence, prevalence, severity, processes of care, and outcomes in a number of rheumatic conditions exist among racial and ethnic groups as compared to white Americans. Furthermore, access to health care and treatment also differs in the minority community as compared with the majority.
The effects of the disease may be modifiable by changes in life style, diet, activities and exercise. Such changes are difficult for patients to accomplish and various strategies have been developed to facilitate success. Strategies include educational materials and programs, diet and exercise programs, patient support and empowerment programs and the like. Differences in culture and environment, lack of culturally sensitive materials and approaches, and lack of trained personnel may make these tools ineffective in the minority community. Their effectiveness in the African-American or Latino clinic population has not been assessed to date.
This is a descriptive, exploratory study designed to examine the diverse health beliefs and behaviors among the minority patients who are enrolled in the NIAMS Natural History of Rheumatic Disease in Minority Communities protocol (# 01-AR-0227). Qualitative and quantitative methodology will be used to assess the psychosocial and cultural correlates of rheumatic diseases in newly enrolled patients both at intake and after six months of being followed at the NIAMS Community Health Center, an outreach site located in the District of Columbia in the Upper Cardozo Health Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Phase I and II Focus Groups and Cognitive Testing of Instruments:
- Previously enrolled patients with known or suspected rheumatic disease and participating in NIAMS protocol # 01-AR-0227 Natural History of Rheumatic Disease in Minority Communities Individuals identified as community leaders or members of the Community Health Partnership will also be included in the focus groups.
- Newly enrolled patients (within 7 days of enrollment on protocol #01-AR-0227) with known or suspected rheumatic disease participating in NIAMS protocol # 01-AR-0227 Natural History of Rheumatic Disease in Minority Communities.
- Age greater than or equal to 18 years.
- Willingness and capacity to provide informed consent
Key exclusion criteria (1 listed)
- Patients will be excluded if any of the inclusion criteria on the parent protocol # 01-AR-0227 cannot be met.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain
Time frame: Cross- Sectional
1 secondary outcome
functional Status -Stanford
Time frame: Cross-Sectional
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 17 Apr 2018.
- Background: PubMed 23071389Wallen GR, Brooks AT. To Tell or Not to Tell: Shared Decision Making, CAM Use and Disclosure Among Underserved Patients with Rheumatic Diseases. Integr Med Insights. 2012;7:15-22. doi: 10.4137/IMI.S10333. Epub 2012 Oct 3.
- Background: PubMed 24701122Brooks AT, Andrade RE, Middleton KR, Wallen GR. Social support: a key variable for health promotion and chronic disease management in Hispanic patients with rheumatic diseases. Clin Med Insights Arthritis Musculoskelet Disord. 2014 Mar 16;7:21-6. doi: 10.4137/CMAMD.S13849. eCollection 2014.
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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.
Gwenyth R Wallen, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by National Institutes of Health Clinical Center (CC) 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 6 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 17 Apr 2018. 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?
Pain (time frame: Cross- Sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00069342, which also lists 2 linked publications.
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 17 Apr 2018.