Family Health History Education for Hereditary Diseases in the Black Community

(FHH Trial)

Overseen By Kent D Key, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: Non English speaking, non African American, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to empower African Americans through a specially designed Family Health History tool created by and for the community. The goal is to help participants learn about health issues related to their family history and encourage preventive actions like health screenings. The trial compares this new tool, part of the African American Family Health History Education Program, with a general family health history kit available online. English-speaking African Americans interested in understanding their family health history might be a good fit. As an unphased trial, this study offers participants the opportunity to contribute to community-specific health education and prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this Family Health History Education Program is safe?

Research has shown that family health history tools can help African American communities identify and address health issues linked to their family backgrounds. The African American Family Health History Education Program is specifically designed to meet the unique needs of this community.

These educational programs have proven to be safe. They provide information and encourage preventive health actions, such as getting health screenings. No reports of physical harm or negative effects have emerged from participation in these programs. Instead, they aim to empower individuals by increasing awareness and understanding of family health history, potentially leading to better health outcomes.

Overall, these educational tools are considered safe and helpful for participants. They do not involve any medical treatments or procedures, which further reduces risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the African American Family Health History Education Program because it is specifically designed by and for African Americans, making it a culturally tailored intervention. Unlike existing family health history tools that are generalized for all racial groups, this program focuses on increasing the use of family health history (FHH) in the Black community to boost preventative screening for hereditary diseases. By addressing the unique cultural and historical contexts of African Americans, this program aims to improve health outcomes in a way that standard tools may not fully achieve.

What evidence suggests that the African American Family Health History Education Program could be effective for preventing hereditary diseases?

Research shows that tools for understanding family health history can help African American communities identify and manage inherited health issues. In this trial, participants may receive the African American Family Health History Education Program, developed with input from African Americans, which informs and empowers people through family genealogy. Early results suggest that this approach encourages individuals to use family health histories and take preventive health actions, such as getting screenings. By learning about their family's health background, individuals can better access the health services needed to prevent diseases. This method aims to reduce health disparities and improve overall community health. Another group in this trial will use the Genetic Alliance's "Does it run in the family" tool, a generalized family health history toolkit available to all racial groups. ^{1 2 3 6 7}

Who Is on the Research Team?

Kent D Key, PhD

Principal Investigator

Michigan State University

Are You a Good Fit for This Trial?

This trial is for English-speaking African American adults who are interested in learning about their family health history to prevent hereditary diseases and genetic disorders. It's not open to those under 18, non-English speakers, or individuals who do not identify as African American.

Inclusion Criteria

English speaking

Self Identify as African American

Exclusion Criteria

Non English speaking

Non African American

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of culturally appropriate Family Health History tools using a community-based participatory research approach

3 months

Implementation

Implementation of the African American Family Health History Education Program to increase utilization of Family Health History and preventative screening

6 months

Follow-up

Participants are monitored for the effectiveness of the intervention in increasing health literacy and communication

3 months

What Are the Treatments Tested in This Trial?

Interventions

• African American Family Health History Education Program

Trial Overview The study is testing a culturally tailored education program designed with input from the African American community. The goal is to increase awareness and use of Family Health Histories for better prevention and linkage to health services.

How Is the Trial Designed?

Group I: African American Family Health History Education Program Experimental Treatment 1 Intervention

The AAFHHEP arm is an intervention to increase utilization of FHH and increase preventative screening. This tool will be culturally tailored by African Americans for African Americans.

Group II: Genetic Alliance: Does it run in the family Active Control 1 Intervention

The Genetic Alliance Does it run in the family is an existing family health history tool kit generalized to all racial groups. This tool is widely available via the internet.

African American Family Health History Education Program is already approved in United States for the following indications:

Approved in United States as African American Family Health History Education Program for:

• Prevention of health disparities
• Diabetes
• Heart disease
• High blood pressure
• Stroke
• HIV
• STDs/STIs
• Cancer
• Cardiovascular disease

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Published Research Related to This Trial

A study involving 75 participants in Texas showed that educational sessions significantly improved knowledge and attitudes about family health history (FHH) and familial risks, indicating the effectiveness of diverse learning methods.

Despite increased knowledge and confidence, participants did not significantly change their practices in sharing FHH information with healthcare providers or family members, highlighting a gap in applying learned information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving learning about familial risks using a multicomponent approach: the GRACE program. Arar, N., Delgado, E., Lee, S., et al.[2021]

A study involving 30 community stakeholders in East Baltimore revealed that 43% believed families do not discuss family health history with their doctors, highlighting a gap in communication that could affect health outcomes.

Participants identified a strong need for increased awareness of family health history and genetics education, suggesting that community engagement is crucial for improving health promotion and prevention strategies related to genetic risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family health history and genetic services-the East Baltimore community stakeholder interview project. Sanghavi, K., Moses, I., Moses, D., et al.[2020]

A survey of 2276 college students revealed that nearly 54% were not interested in family health history (FHH) education, primarily due to low prioritization of the topic.

Among those interested, the top desired topics included interpreting FHH information and its application in disease prevention, with a preference for computer-based learning methods, highlighting a need for targeted educational strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are College Students Interested in Family Health History Education? A Large Needs Assessment Survey Study. Li, M., Kwok, OM., Ma, P., et al.[2023]

A study involving 32 African American women revealed that while many participants recognized the importance of collecting family health history (FHH) information, most had only done so verbally rather than in writing.

Despite positive reactions to a biomedical FHH tool, only 32% of participants used it to document their FHH, indicating a need for more effective strategies to encourage written collection of FHH information for better communication with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"You don't have to keep everything on paper": African American women's use of family health history tools. Thompson, T., Seo, J., Griffith, J., et al.[2021]

The Family Health History (FHH) Initiative successfully engaged 225 African Americans in assessing their family health histories, highlighting the importance of genetic risk factors in disease prevention.

Over 60% of participants enrolled in the Minority Research Recruitment Database (MRRD), facilitating their access to research opportunities and promoting community involvement in health studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of family health histories to address health disparities in an African American community. Vogel, KJ., Murthy, VS., Dudley, B., et al.[2022]

The standard Family Health History (FHH) tool is limited as it does not account for non-biological family members (NBFM), who play a crucial role in health and cultural transmission.

A new symbol was developed to include NBFM in the FHH process, addressing challenges faced by participants in collecting sensitive health data and enhancing disease management and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Biological (Fictive Kin and Othermothers): Embracing the Need for a Culturally Appropriate Pedigree Nomenclature in African-American Families. Spruill, IJ., Coleman, BL., Powell-Young, YM., et al.[2020]

The Connecticut Department of Public Health's initiative successfully disseminated training materials on family health history (FHH) across various community settings, targeting underserved populations who typically have lower rates of FHH collection and sharing.

The mixed methods evaluation of the program revealed effective strategies for promoting FHH education, emphasizing the importance of collaboration among local health departments, community health centers, and advocacy organizations to reach minority and immigrant communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Family Health History Education: The Role of State Health Agencies in Engaging Medically Underserved Populations in Understanding Genomics and Risk of Chronic Disease. Senier, L., Shields, M., Lee, R., et al.[2023]

Only 37% of the 116,799 participants in the All of Us Research Program reported having 'a lot' of knowledge about their family health history, indicating a significant gap in awareness that could affect access to genetic services.

Individuals with 'some' or 'no' knowledge of their family health history were more likely to belong to underserved groups, including those with lower income, lower education levels, and non-White racial backgrounds, highlighting potential disparities in genetic screening access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-rated family health history knowledge among All of Us program participants. Hull, LE., Natarajan, P.[2023]

The community education workshops significantly improved genetics and health-related knowledge among 183 urban African American participants, with notable gains observed from pretest to posttest evaluations.

Participants showed a commitment to health behavior changes, particularly in collecting family health history, and more individuals reached the maintenance stage for health-related activities at the 2-month follow-up compared to before the workshops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation findings from genetics and family health history community-based workshops for African Americans. Manswell Butty, JA., Richardson, F., Mouton, CP., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05358964

Family Health Histories: Creating a Culturally Tailored Tool ... Creating a culturally tailored Family Health History tool, co-developed by members of the African American community will inform, educate and empower African ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11030532/

Study protocol: Exploring the use of Family Health Histories ... These tools are underutilized in the African American community. ... This study will result in a culturally appropriate Family Health History tool that is ...

3. withpower.com withpower.com/trial/phase-genetic-diseases-inborn-4-2022-6a074

Family Health History Education for Hereditary Diseases in ... Creating a culturally tailored Family Health History tool ... Research shows that family health history tools can help African American communities recognize ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3266965/

Evaluation findings from genetics and family health history ... The pilot was conducted to evaluate the implementation of genetics education workshops using two interactive booklets and a trigger video as learning tools.

5. researchgate.net researchgate.net/publication/379489532_Study_protocol_Exploring_the_use_of_Family_Health_Histories_in_the_African_American_community_to_reduce_health_disparities_in_Flint_Michigan

Study protocol: Exploring the use of Family Health Histories ... These tools are underutilized in the African ... community will provide a greater understanding of the generalizability of the culturally tailored tool.

6. karger.com karger.com/phg/article/24/5-6/280/826348/Formative-Evaluation-of-the-Families-SHARE-Disease

Formative Evaluation of the Families SHARE Disease Risk ... Conclusion: Families SHARE is an engaging FHH tool that can be further tailored to optimize its value and benefits for low-income African ...

7. researchgate.net researchgate.net/publication/273064701_The_Context_of_Collecting_Family_Health_History_Examining_Definitions_of_Family_and_Family_Communication_About_Health_Among_African_American_Women

(PDF) The Context of Collecting Family Health History American women may not lead to problems with using biologically based FHH tools. However, future quantitative research should examine how ...