Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the Black Community

Hereditary Diseases Clinical Trial

— FHH  

Official title:

Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the African American Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358964
• Other study ID #: 00005570
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2024
• Source: Michigan State University
• Contact: Kent D Key, PhD
• Phone: 810-600-5663
• Email: keykent[@]msu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The understanding, utilization and uptake of Family Health History is essential to the prevention of health disparities in the African American community. Creating a culturally tailored Family Health History tool, co-developed by members of the African American community will inform, educate and empower African Americans about health issues related to their family genealogy. Applying the knowledge gained via Family Health Histories to increase preventative behaviors including screenings thus linking people to needed health services to prevent the onset of disease and illness.

Description:

African Americans (AA) suffer disproportionately across most health disparities (HD). Preventative behaviors including screenings can inform proactive measures to address many HD which include: diabetes, heart disease, high blood pressure, stroke, HIV, STDs/STIs, cancer, and cardiovascular disease, most of which can be prevented.1-3 Evidence suggests that a lack of general health literacy (HL) and racially appropriate health communication strategies may contribute to the consistent high rates of health disparities in the AA community. Family Health Histories (FHH), which describe genetic and other familial contributions to health, have been identified as an effective tool for prevention and early detection and screenings. The underutilization of FHHs in AA communities negatively impacts screening and preventative measures that could prevent the onset of disease, illness and ultimately death.4 Although many FHH toolkits have been created to assist families in gathering FHH information, these tools typically are mostly focused for the general population and do not account for the cultural and ethnic nuances, communication preference and health literacy levels of the African American community.4 The failure to effectively engage AA in the creation and conception of culturally relevant FHH tools and activities to date likely contributes to their underutilization in this population.

The objective of this K01 is to develop culturally appropriate FHH tools designed for broad understanding and uptake in AA communities. The central hypothesis of this proposal is that, using a community based participatory research (CBPR) approach, co-development of a culturally appropriate FHH toolkit will increase the utility and engagement of AA families in FHH activities; increase effective health communication within the family structure; and increase the health literacy of participants in a multifaceted effort to reduce and ultimately eliminate racial and ethnic health disparities. Flint is an ideal community in which to conduct this participatory research because the recent events of the Flint Water Crisis have created interest in genetics and FHH in the AA community as a result of community concern around the generational impacts of bacteria and lead exposure on health. Therefore, we will have partners within AA communities in Flint who will be motivated to partner with us to develop these tools for Flint and for other minority communities.

This career development award is being submitted by Dr. Kent Key, a candidate with extensive experience in CBPR and a solid foundation in qualitative and health disparities research. To reach his long term goal of becoming an R01-funded researcher in CBPR to reduce health disparities by increasing health literacy and using effective health communication strategies to reduce and ultimately eliminate racial health disparities for African-American populations, this K01 will provide additional training in the following areas: (1) intervention development and design and conduct of randomized trials, (2) health communication models, (3) health literacy promotion, (4) CBPR approaches to Genomics and Genetics, (5) biostatistics, (6) grant-writing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self Identify as African American; age 18 and older, English speaking

Exclusion Criteria:

• Non English speaking, non African American, younger than 18 years old

Related Conditions & MeSH terms

• Genetic Diseases, Inborn
• Hereditary Diseases

Intervention

Behavioral:
• African American Family Health History Education Program
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.

Locations

Country	Name	City	State
United States	Michigan State University	Flint	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health literacy	We will evaluate health literacy using the Health Literacy Questionnaire (HLQ)	3 months
Other	Health literacy	We will evaluate health literacy using the Health Literacy Questionnaire (HLQ)	6 months
Other	Health communication	We will evaluate health communication using the Health Literacy Questionnaire (HLQ)	3 months
Other	Health communication	We will evaluate health communication using the Health Literacy Questionnaire (HLQ)	6 months
Primary	Use of Family Health History with Family	We will evaluate the length of conversations (minutes per month) with family using a modified Genetic Alliance Assessment	3 month
Primary	Use of Family Health History with Physician	We will evaluate the length of conversations (minutes per month) with physician using a modified Genetic Alliance Assessment	3 months
Primary	Quality of Family Health History Discussions	We will evaluate the quality of conversations using the Genetic Alliance Assessment	3 months
Primary	Quality of Family Health History Discussions	We will evaluate the quality of conversations using the Genetic Alliance Assessment	6 months
Primary	Acceptability: End of Intervention/Treatment Questionnaire	End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability	3 months
Primary	Acceptability: End of Intervention/Treatment Questionnaire	End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability	6 months
Primary	Feasibility: End of Intervention/Treatment Questionnaire	End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability	3 months
Primary	Feasibility: End of Intervention/Treatment Questionnaire	End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability	6 months
Primary	Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)	CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction	3 months
Primary	Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)	CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction	6 months
Primary	Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)	CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction	3 months
Primary	Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)	CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction	6 months
Secondary	Satisfaction with Family Health History	We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)	3 months
Secondary	Satisfaction with Family Health History	We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)	6 months
Secondary	Understandability	We will evaluate understandability using the Health Literacy Questionnaire (HLQ)	3 months
Secondary	Understandability	We will evaluate understandability using the Health Literacy Questionnaire (HLQ)	6 months
Secondary	Number of screenings requested	We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)	3 months
Secondary	Number of screenings requested	We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)	6 months