Healthy VolunteersNCT00441077
Interventions to Educate An Underserved Population About Inherited Disease Risks
A study testing Education in people with Healthy Volunteers, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
Trial summary
This study will examine how to communicate with an underserved population about inherited disease risks. It will present information about inherited risk to a Latino population through either a lay health advisor (LHA) or through printed information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 550 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2007to 12 Dec 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants in this study will be healthy volunteers. Eligibility criteria for participation in the study are the following: (1) being at least 18 years of age; and (2) being able to speak Spanish and having basic Spanish reading and writing skills.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
La Raza
Oakland, California
La Clinica del Pueblo
Washington D.C., District of Columbia, 20009
About this study
Official title: Using a Communication Intervention to Provide Information About Inherited Risk to Underserved Latino Communities
This study will examine how to communicate with an underserved population about inherited disease risks. It will present information about inherited risk to a Latino population through either a lay health advisor (LHA) or through printed information. The LHA is a member of the Latino community who has received training in public speaking, group facilitation, and managing group dynamics and in family health history and genetics. Previous studies have shown that an LHA can effectively communicate health information to diverse audiences, but such interventions have not been studied in the context of inherited risk.
Spanish-speaking Latino men and women over the age of 18 in the Oakland, CA, and Washington, DC, areas who have basic Spanish reading and writing skills may be eligible for this study.
Read more
Participants are recruited to one of two groups. One group participates in group educational sessions with an LHA about inherited disease risks and family health history, and the other receives this information from a brochure.
Educational Sessions
Groups of 5 to 8 individuals complete a questionnaire and then participate in a 45-minute educational session on concepts related to genetics, family health history, lifestyle and environment. Participants engage in role-playing to practice discussing family health history with family members. The LHA teaches participants the skills needed to fill in family health history tool called My Family Health Portrait and answers questions. After the question and answer session, participants complete a second questionnaire.
Brochure-Only
Participants complete a questionnaire and then read a Spanish-language brochure produced by the U.S. Surgeon General's Office about the importance of knowing one's family history. They then complete a second questionnaire.
Read the detailed description
How to effectively educate the public about inherited risk is an important communication issue now and will likely become even more important over the next decade. Little research has been conducted, however, to examine how to communicate about this topic with individuals from underserved populations. The planned study provides a unique and innovative opportunity to examine how to reach an underserved community and present information about inherited risk in an understandable and usable form by building upon an existing relationship between NHGRI and the National Council of La Raza (NCLR). NCLR has previously designed a culturally tailored lay health advisor (LHA) intervention designed to increase knowledge and awareness about inherited risk among Latinos and to motivate them to seek information about their family history. The primary objective of this study will be to examine the pathways by which the LHA communication intervention impacts information seeking outcome variables. We will examine the roles of possible mediating variables (i.e., perceived information need, conceptual knowledge, self-efficacy) and assess the effects of contextual variables (i.e., family and personal history of disease, genetic beliefs, acculturation, health care access, sociodemographic variables) on the outcomes. The second objective is to provide quantitative data on the effects of the intervention on information seeking outcome measures (i.e., discussing family history with family members and health care providers) by comparing the intervention to a brochure-only condition; these data can inform the planning of a large-scale randomized controlled intervention trial. A third objective is to examine predictors of intention to seek information about family history at baseline. A quasi-experimental design will be used; we will recruit 350 individuals to participate in the LHA intervention and 200 to a brochure-only comparison group. All participants will be Spanish-speaking healthy volunteers who are at least 18 years of age and have basic Spanish reading and writing skills. Participants will be recruited through community-based clinics in Oakland, CA and Washington, DC and will either participate in a LHA or be asked to read information about family history. They will complete brief, self-administered questionnaires in Spanish before and after participating in the intervention or reading the brochure. Because of the quasi-experimental design, multiple logistic regression models will be used in the analysis in order to control for covariates. Understanding how to effectively inform underserved communities about inherited risk is a research area of critical importance if genomics is to be used to benefit the public health.
- Conditions
- Healthy Volunteers
- Being tested
- Education
- Keywords
- Genetics, Family History, Latino, Information Seeking, Lay Health Advisors, Cancer, Heart Disease, Diabetes, Information
- Medical subject headings
- Neoplasms, Heart Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Intentions to seek information about family history.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study start19 Feb 2007
- Primary completion12 Dec 2007
- Study completion12 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441077
- Sponsor's protocol ID
- 999907102
- Other IDs
- 07-HG-N102
- Status last verified
- 25 Aug 2009
- First submitted
- 27 Feb 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Balcazar H, Alvarado M, Hollen ML, Gonzalez-Cruz Y, Pedregon V. Evaluation of Salud Para Su Corazon (Health for your Heart) -- National Council of La Raza Promotora Outreach Program. Prev Chronic Dis. 2005 Jul;2(3):A09. Epub 2005 Jun 15.
PubMed 15963311Catz DS, Green NS, Tobin JN, Lloyd-Puryear MA, Kyler P, Umemoto A, Cernoch J, Brown R, Wolman F. Attitudes about genetics in underserved, culturally diverse populations. Community Genet. 2005;8(3):161-72. doi: 10.1159/000086759.
PubMed 16113533Derose KP, Baker DW. Limited English proficiency and Latinos' use of physician services. Med Care Res Rev. 2000 Mar;57(1):76-91. doi: 10.1177/107755870005700105.
PubMed 10705703
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Communication Intervention to Provide Information About Inherited Risk to Underserved Latino Communities
- ClinicalTrials.gov ID
- NCT00441077
- Acronym / sponsor ID
- 999907102
- Conditions
- Healthy Volunteers
- Keywords
- Genetics, Family History, Latino, Information Seeking, Lay Health Advisors, Cancer, Heart Disease, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 19 Feb 2007
- Primary completion
- 12 Dec 2007 (actual)
- Study completion
- 12 Dec 2007 (actual)
- First posted
- 28 Feb 2007 (estimated)
- 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.
This study will examine how to communicate with an underserved population about inherited disease risks. It will present information about inherited risk to a Latino population through either a lay health advisor (LHA) or through printed information. The LHA is a member of the Latino community who has received training in public speaking, group facilitation, and managing group dynamics and in family health history and genetics. Previous studies have shown that an LHA can effectively communicate health information to diverse audiences, but such interventions have not been studied in the context of inherited risk.
Spanish-speaking Latino men and women over the age of 18 in the Oakland, CA, and Washington, DC, areas who have basic Spanish reading and writing skills may be eligible for this study.
Participants are recruited to one of two groups. One group participates in group educational sessions with an LHA about inherited disease risks and family health history, and the other receives this information from a brochure.
Educational Sessions
Groups of 5 to 8 individuals complete a questionnaire and then participate in a 45-minute educational session on concepts related to genetics, family health history, lifestyle and environment. Participants engage in role-playing to practice discussing family health history with family members. The LHA teaches participants the skills needed to fill in family health history tool called My Family Health Portrait and answers questions. After the question and answer session, participants complete a second questionnaire.
Brochure-Only
Participants complete a questionnaire and then read a Spanish-language brochure produced by the U.S. Surgeon General's Office about the importance of knowing one's family history. They then complete a second questionnaire.
Detailed description
How to effectively educate the public about inherited risk is an important communication issue now and will likely become even more important over the next decade. Little research has been conducted, however, to examine how to communicate about this topic with individuals from underserved populations. The planned study provides a unique and innovative opportunity to examine how to reach an underserved community and present information about inherited risk in an understandable and usable form by building upon an existing relationship between NHGRI and the National Council of La Raza (NCLR). NCLR has previously designed a culturally tailored lay health advisor (LHA) intervention designed to increase knowledge and awareness about inherited risk among Latinos and to motivate them to seek information about their family history. The primary objective of this study will be to examine the pathways by which the LHA communication intervention impacts information seeking outcome variables. We will examine the roles of possible mediating variables (i.e., perceived information need, conceptual knowledge, self-efficacy) and assess the effects of contextual variables (i.e., family and personal history of disease, genetic beliefs, acculturation, health care access, sociodemographic variables) on the outcomes. The second objective is to provide quantitative data on the effects of the intervention on information seeking outcome measures (i.e., discussing family history with family members and health care providers) by comparing the intervention to a brochure-only condition; these data can inform the planning of a large-scale randomized controlled intervention trial. A third objective is to examine predictors of intention to seek information about family history at baseline. A quasi-experimental design will be used; we will recruit 350 individuals to participate in the LHA intervention and 200 to a brochure-only comparison group. All participants will be Spanish-speaking healthy volunteers who are at least 18 years of age and have basic Spanish reading and writing skills. Participants will be recruited through community-based clinics in Oakland, CA and Washington, DC and will either participate in a LHA or be asked to read information about family history. They will complete brief, self-administered questionnaires in Spanish before and after participating in the intervention or reading the brochure. Because of the quasi-experimental design, multiple logistic regression models will be used in the analysis in order to control for covariates. Understanding how to effectively inform underserved communities about inherited risk is a research area of critical importance if genomics is to be used to benefit the public health.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants in this study will be healthy volunteers. Eligibility criteria for participation in the study are the following: (1) being at least 18 years of age; and (2) being able to speak Spanish and having basic Spanish reading and writing skills.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education | Behavioural | – |
Primary outcome
Intentions to seek information about family history.
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 2 Jul 2017.
- Background: PubMed 15963311Balcazar H, Alvarado M, Hollen ML, Gonzalez-Cruz Y, Pedregon V. Evaluation of Salud Para Su Corazon (Health for your Heart) -- National Council of La Raza Promotora Outreach Program. Prev Chronic Dis. 2005 Jul;2(3):A09. Epub 2005 Jun 15.
- Background: PubMed 16113533Catz DS, Green NS, Tobin JN, Lloyd-Puryear MA, Kyler P, Umemoto A, Cernoch J, Brown R, Wolman F. Attitudes about genetics in underserved, culturally diverse populations. Community Genet. 2005;8(3):161-72. doi: 10.1159/000086759.
- Background: PubMed 10705703Derose KP, Baker DW. Limited English proficiency and Latinos' use of physician services. Med Care Res Rev. 2000 Mar;57(1):76-91. doi: 10.1177/107755870005700105.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Healthy Volunteers, 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 1 inclusion and 0 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 2 Jul 2017. 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?
Intentions to seek information about family history.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00441077, which also lists 3 linked publications.
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 2 Jul 2017.