Clinical trial NCT05358964: Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the Black Community
Official title: Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the African American Community
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hereditary Diseases
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants assigned to the AFFHEP will receive a culturally tailored Family Health History Tool designed specifically for African Americans. The Control group will receive the Genetic Alliance Does it Run in the Family Toolkit
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of Family Health History with Family
timeFrame: 3 month
measure: Use of Family Health History with Physician
timeFrame: 3 months
measure: Quality of Family Health History Discussions
timeFrame: 3 months
measure: Quality of Family Health History Discussions
timeFrame: 6 months
measure: Acceptability: End of Intervention/Treatment Questionnaire
timeFrame: 3 months
measure: Acceptability: End of Intervention/Treatment Questionnaire
timeFrame: 6 months
measure: Feasibility: End of Intervention/Treatment Questionnaire
timeFrame: 3 months
measure: Feasibility: End of Intervention/Treatment Questionnaire
timeFrame: 6 months
measure: Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
timeFrame: 3 months
measure: Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
timeFrame: 6 months
measure: Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
timeFrame: 3 months
measure: Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
timeFrame: 6 months
Secondary outcomes:
measure: Satisfaction with Family Health History
timeFrame: 3 months
measure: Satisfaction with Family Health History
timeFrame: 6 months
measure: Understandability
timeFrame: 3 months
measure: Understandability
timeFrame: 6 months
measure: Number of screenings requested
timeFrame: 3 months
measure: Number of screenings requested
timeFrame: 6 months
Other outcomes:
measure: Health literacy
timeFrame: 3 months
measure: Health literacy
timeFrame: 6 months
measure: Health communication
timeFrame: 3 months
measure: Health communication
timeFrame: 6 months
Locations:
city: Flint
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Kent D Key, PhD
role: PRINCIPAL_INVESTIGATOR
References: