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

January 18, 2024 updated by: National Human Genome Research Institute (NHGRI)

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.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
      • Bethesda, Maryland, United States, 20892
        • National Human Genome Research Institute (NHGRI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
family members
family members of those with rheumatoid arthritis
rheumatoid arthritis
persons with rheumatoid arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family networks
Time Frame: One time
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Jielu Lin, Ph.D., National Human Genome Research Institute (NHGRI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2022

Primary Completion (Actual)

January 9, 2024

Study Completion (Actual)

January 9, 2024

Study Registration Dates

First Submitted

July 9, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000912
  • 000912-HG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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