NCT05457816

Brief Summary

Background: Rheumatoid arthritis (RA) is more severe in Hispanic people. Genetics plays a role. But social issues may also lead to more severe RA in Hispanics. Some Hispanics may not seek help for early symptoms. Support from family and friends may persuade people to seek treatment earlier. Researchers want to learn more about how social factors affect RA in Hispanics. Objective: This natural history study will explore genetic and social factors related to RA in Hispanic families. Eligibility: People aged 18 years or older of Hispanic/Latino heritage. They may have RA or RA symptoms; they may also have a relative or partner with RA or RA symptoms. Design: Participants will receive an email or text with a link to a 30-minute online survey. They will answer questions about these things: Physical and emotional health How health problems affect their life Family history of RA and other conditions Cultural identity and language preference Participants may also answer these questions in a phone call or an in-person interview. Participants will be asked to list people in their social network. They will answer questions about those relationships. They will be asked if they want to invite their family and friends to participate in the study. If more than 1 person from a participant s family takes part in the study, they may be invited for an interview. They will answer questions about how arthritis pain affects their mind and body. Participants will give a sample of saliva. They will spit into a vial. They will mail it in using a prepaid label.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

July 9, 2022

Last Update Submit

January 18, 2024

Conditions

Keywords

JointPainHealth Service UseImmigrantsNatural History

Outcome Measures

Primary Outcomes (1)

  • Family networks

    Evaluate the associations between family networks, RA-related health communication and use of health service, and RA severity across levels of genetic susceptibility

    One time

Study Arms (2)

family members

family members of those with rheumatoid arthritis

rheumatoid arthritis

persons with rheumatoid arthritis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants of Hispanic origin experiencing rheumatoid arthritis (RA) symptoms and their family members

You may qualify if:

  • Consistent with the study objective, to be eligible to participate in this study, an individual must meet all of the following:
  • Age 18 and over;
  • Able to speak either English or Spanish;
  • Of Hispanic/Latino heritage (regardless of country of origin);
  • Meeting one of the following: (a) has RA or RA symptoms, (b) has at least one biological kin who has RA or RA symptoms, (c) has a spouse/partner who has RA or RA symptoms. It is not required to have an official diagnosis or records of symptoms. The screening questionnaire will screen prospective participants for either a confirmed diagnosis of RA or presence of inflammatory polyarthritis (pain, swelling and stiffness in three or more joints), which is the evaluation criterion for suspected RA in absence of laboratory testing, for themselves or their biological relatives or spouse/partner;
  • Able and willing to give written informed consent.

You may not qualify if:

  • This is a study being conducted at NHGRI s intramural research program. Therefore, NHGRI staff will be excluded from as a safeguard against the risk of ethical concerns.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Human Genome Research Institute (NHGRI)

Bethesda, Maryland, 20892, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jielu Lin, Ph.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 9, 2022

First Posted

July 14, 2022

Study Start

November 21, 2022

Primary Completion

January 9, 2024

Study Completion

January 9, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations