NCT00069342

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2003

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 23, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2003

Completed
14.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 12, 2018

First QC Date

September 23, 2003

Last Update Submit

April 13, 2018

Conditions

Keywords

Chronic PainPainRheumatoid ArthritisDepressionFunctionRheumatic Disease

Outcome Measures

Primary Outcomes (1)

  • Pain

    Cross- Sectional

Secondary Outcomes (1)

  • functional Status -Stanford

    Cross-Sectional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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.

    PMID: 23071389BACKGROUND
  • Brooks 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.

    PMID: 24701122BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidLupus Erythematosus, SystemicArthritisChronic PainPainDepressionRheumatic Diseases

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Gwenyth R Wallen, Ph.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2003

First Posted

September 24, 2003

Study Start

September 22, 2003

Study Completion

April 12, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04-12

Locations