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

September 8, 2025 updated by: Kent Key, Michigan State University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Michigan
      • Flint, Michigan, United States, 48502
        • Recruiting
        • Michigan State University
        • Principal Investigator:
          • Kent D Key, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • AAFHHEP
Active Comparator: Genetic Alliance: Does it run in the family
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.
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.
Other Names:
  • AAFHHEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Family Health History with Family
Time Frame: 3 month
We will evaluate the length of conversations (minutes per month) with family using a modified Genetic Alliance Assessment
3 month
Use of Family Health History with Physician
Time Frame: 3 months
We will evaluate the length of conversations (minutes per month) with physician using a modified Genetic Alliance Assessment
3 months
Quality of Family Health History Discussions
Time Frame: 3 months
We will evaluate the quality of conversations using the Genetic Alliance Assessment
3 months
Quality of Family Health History Discussions
Time Frame: 6 months
We will evaluate the quality of conversations using the Genetic Alliance Assessment
6 months
Acceptability: End of Intervention/Treatment Questionnaire
Time Frame: 3 months
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
3 months
Acceptability: End of Intervention/Treatment Questionnaire
Time Frame: 6 months
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
6 months
Feasibility: End of Intervention/Treatment Questionnaire
Time Frame: 3 months
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
3 months
Feasibility: End of Intervention/Treatment Questionnaire
Time Frame: 6 months
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
6 months
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
Time Frame: 3 months
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
3 months
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
Time Frame: 6 months
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
6 months
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
Time Frame: 3 months
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
3 months
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
Time Frame: 6 months
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Family Health History
Time Frame: 3 months
We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)
3 months
Satisfaction with Family Health History
Time Frame: 6 months
We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)
6 months
Understandability
Time Frame: 3 months
We will evaluate understandability using the Health Literacy Questionnaire (HLQ)
3 months
Understandability
Time Frame: 6 months
We will evaluate understandability using the Health Literacy Questionnaire (HLQ)
6 months
Number of screenings requested
Time Frame: 3 months
We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)
3 months
Number of screenings requested
Time Frame: 6 months
We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health literacy
Time Frame: 3 months
We will evaluate health literacy using the Health Literacy Questionnaire (HLQ)
3 months
Health literacy
Time Frame: 6 months
We will evaluate health literacy using the Health Literacy Questionnaire (HLQ)
6 months
Health communication
Time Frame: 3 months
We will evaluate health communication using the Health Literacy Questionnaire (HLQ)
3 months
Health communication
Time Frame: 6 months
We will evaluate health communication using the Health Literacy Questionnaire (HLQ)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kent D Key, PhD, Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 00005570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share individual participant data with other researchers. Will will only share data results and summarized data via presentations and manuscript publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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