Rheumatoid ArthritisNCT05457816
Genetic and Social Network Correlates of Rheumatoid Arthritis Outcomes in Hispanic Populations: A Prospective Study
An observational study of Rheumatoid Arthritis, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2022to 9 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants of Hispanic origin experiencing rheumatoid arthritis (RA) symptoms and their family members
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, 20892
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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
- Conditions
- Rheumatoid Arthritis
- Keywords
- Joint, Pain, Health Service Use, Immigrants, Natural History
- Medical subject headings
- Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| family members | family members of those with rheumatoid arthritis | |
| rheumatoid arthritis | persons with rheumatoid arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start21 Nov 2022
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jielu Lin, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457816
- Sponsor's protocol ID
- 10000912
- Other IDs
- 000912-HG
- Status last verified
- Jan 2024
- First submitted
- 9 Jul 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Social Network Correlates of Rheumatoid Arthritis Outcomes in Hispanic Populations: A Prospective Study
- ClinicalTrials.gov ID
- NCT05457816
- Acronym / sponsor ID
- 10000912
- Conditions
- Rheumatoid Arthritis
- Keywords
- Joint, Pain, Health Service Use, Immigrants, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| family members | – | –family members of those with rheumatoid arthritis |
| rheumatoid arthritis | – | –persons with rheumatoid arthritis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants of Hispanic origin experiencing rheumatoid arthritis (RA) symptoms and their family members
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jielu Lin, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family networks (time frame: One time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.