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

Sponsor
Michigan State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05358964
Collaborator
(none)
100
1
2
45
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: African American Family Health History Education Program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 ToolkitParticipants 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
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the African American Community
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jan 31, 2026
Anticipated Study Completion Date :
Jan 31, 2026

Arms and Interventions

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.

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.
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.

    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.
    Other Names:
  • AAFHHEP
  • Outcome Measures

    Primary Outcome Measures

    1. Use of Family Health History with Family [3 month]

      We will evaluate the length of conversations (minutes per month) with family using a modified Genetic Alliance Assessment

    2. Use of Family Health History with Physician [3 months]

      We will evaluate the length of conversations (minutes per month) with physician using a modified Genetic Alliance Assessment

    3. Quality of Family Health History Discussions [3 months]

      We will evaluate the quality of conversations using the Genetic Alliance Assessment

    4. Quality of Family Health History Discussions [6 months]

      We will evaluate the quality of conversations using the Genetic Alliance Assessment

    5. Acceptability: End of Intervention/Treatment Questionnaire [3 months]

      End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability

    6. Acceptability: End of Intervention/Treatment Questionnaire [6 months]

      End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability

    7. Feasibility: End of Intervention/Treatment Questionnaire [3 months]

      End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability

    8. Feasibility: End of Intervention/Treatment Questionnaire [6 months]

      End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability

    9. Acceptability: Client Satisfaction Questionnaire (CSQ-8-R) [3 months]

      CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction

    10. Acceptability: Client Satisfaction Questionnaire (CSQ-8-R) [6 months]

      CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction

    11. Feasibility: Client Satisfaction Questionnaire (CSQ-8-R) [3 months]

      CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction

    12. Feasibility: Client Satisfaction Questionnaire (CSQ-8-R) [6 months]

      CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction

    Secondary Outcome Measures

    1. Satisfaction with Family Health History [3 months]

      We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)

    2. Satisfaction with Family Health History [6 months]

      We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)

    3. Understandability [3 months]

      We will evaluate understandability using the Health Literacy Questionnaire (HLQ)

    4. Understandability [6 months]

      We will evaluate understandability using the Health Literacy Questionnaire (HLQ)

    5. Number of screenings requested [3 months]

      We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)

    6. Number of screenings requested [6 months]

      We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)

    Other Outcome Measures

    1. Health literacy [3 months]

      We will evaluate health literacy using the Health Literacy Questionnaire (HLQ)

    2. Health literacy [6 months]

      We will evaluate health literacy using the Health Literacy Questionnaire (HLQ)

    3. Health communication [3 months]

      We will evaluate health communication using the Health Literacy Questionnaire (HLQ)

    4. Health communication [6 months]

      We will evaluate health communication using the Health Literacy Questionnaire (HLQ)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Michigan State University Flint Michigan United States 48502

    Sponsors and Collaborators

    • Michigan State University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kent Key, Assistant Professor, Michigan State University
    ClinicalTrials.gov Identifier:
    NCT05358964
    Other Study ID Numbers:
    • 00005570
    First Posted:
    May 3, 2022
    Last Update Posted:
    May 3, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2022