Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00069342|
Recruitment Status : Completed
First Posted : September 24, 2003
Last Update Posted : April 17, 2018
|First Submitted Date||September 23, 2003|
|First Posted Date||September 24, 2003|
|Last Update Posted Date||April 17, 2018|
|Study Start Date||September 22, 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Pain [ Time Frame: Cross- Sectional ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00069342 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||functional Status -Stanford [ Time Frame: Cross-Sectional ]|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases|
|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.
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.
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.
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
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||April 12, 2018|
|Primary Completion Date||Not Provided|
A. 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.
B. Age greater than or equal to 18 years.
C. Willingness and capacity to provide informed consent
Patients will be excluded if any of the inclusion criteria on the parent protocol # 01-AR-0227 cannot be met.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||030301
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor||National Institutes of Health Clinical Center (CC)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 12, 2018|