Genetic and Social Network Correlates of Rheumatoid Arthritis Outcomes in Hispanic Populations: A Prospective Study

Rheumatoid Arthritis Clinical Trial

Official title:

Genetic and Social Network Correlates of Rheumatoid Arthritis Outcomes in Hispanic Populations: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05457816
• Other study ID #: 10000912
• Secondary ID: 000912-HG
• Status: Completed
• Start date: November 21, 2022
• Est. completion date: January 9, 2024

Study information

• Verified date: January 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study Description:

Adult participants of Hispanic origin experiencing rheumatoid arthritis (RA) symptoms and their family members will be invited to participate in surveys and interviews to assess RA severity (affected individuals only), functional limitations, psychological well-being, use of health service, and family networks. Genotyping will be performed on saliva samples collected from consenting participants to evaluate genetic risk of severe RA in the population under study.

Objectives:

The primary objective is to identify the interpersonal mechanisms underlying RA-related health communication and health service use in Hispanic populations. The secondary objective is to characterize genetic risk of severe RA in Hispanic populations and determine how interpersonal mechanisms moderate such genetic risk.

Endpoints:

Primary Endpoint: Evaluate the associations between structural properties of the participants personal networks and RA-related health communication and use of health service

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

• INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	National Human Genome Research Institute (NHGRI)	Bethesda	Maryland
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NIH Clinical Center Detailed Web Page