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

Primary Purpose

Hereditary Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
African American Family Health History Education Program
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hereditary Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Michigan State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

African American Family Health History Education Program

Genetic Alliance: Does it run in the family

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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
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
Quality of Family Health History Discussions
We will evaluate the quality of conversations using the Genetic Alliance Assessment
Quality of Family Health History Discussions
We will evaluate the quality of conversations using the Genetic Alliance Assessment
Acceptability: End of Intervention/Treatment Questionnaire
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Acceptability: End of Intervention/Treatment Questionnaire
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Feasibility: End of Intervention/Treatment Questionnaire
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Feasibility: End of Intervention/Treatment Questionnaire
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction

Secondary Outcome Measures

Satisfaction with Family Health History
We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)
Satisfaction with Family Health History
We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)
Understandability
We will evaluate understandability using the Health Literacy Questionnaire (HLQ)
Understandability
We will evaluate understandability using the Health Literacy Questionnaire (HLQ)
Number of screenings requested
We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)
Number of screenings requested
We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)

Full Information

First Posted
March 14, 2022
Last Updated
October 18, 2023
Sponsor
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT05358964
Brief Title
Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the Black Community
Acronym
FHH
Official Title
Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the African American Community
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
African American Family Health History Education Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Genetic Alliance: Does it run in the family
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
African American Family Health History Education Program
Other Intervention Name(s)
AAFHHEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Use of Family Health History with Family
Description
We will evaluate the length of conversations (minutes per month) with family using a modified Genetic Alliance Assessment
Time Frame
3 month
Title
Use of Family Health History with Physician
Description
We will evaluate the length of conversations (minutes per month) with physician using a modified Genetic Alliance Assessment
Time Frame
3 months
Title
Quality of Family Health History Discussions
Description
We will evaluate the quality of conversations using the Genetic Alliance Assessment
Time Frame
3 months
Title
Quality of Family Health History Discussions
Description
We will evaluate the quality of conversations using the Genetic Alliance Assessment
Time Frame
6 months
Title
Acceptability: End of Intervention/Treatment Questionnaire
Description
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Time Frame
3 months
Title
Acceptability: End of Intervention/Treatment Questionnaire
Description
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Time Frame
6 months
Title
Feasibility: End of Intervention/Treatment Questionnaire
Description
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Time Frame
3 months
Title
Feasibility: End of Intervention/Treatment Questionnaire
Description
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Time Frame
6 months
Title
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
Description
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Time Frame
3 months
Title
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
Description
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Time Frame
6 months
Title
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
Description
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Time Frame
3 months
Title
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
Description
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Satisfaction with Family Health History
Description
We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)
Time Frame
3 months
Title
Satisfaction with Family Health History
Description
We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)
Time Frame
6 months
Title
Understandability
Description
We will evaluate understandability using the Health Literacy Questionnaire (HLQ)
Time Frame
3 months
Title
Understandability
Description
We will evaluate understandability using the Health Literacy Questionnaire (HLQ)
Time Frame
6 months
Title
Number of screenings requested
Description
We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)
Time Frame
3 months
Title
Number of screenings requested
Description
We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Health literacy
Description
We will evaluate health literacy using the Health Literacy Questionnaire (HLQ)
Time Frame
3 months
Title
Health literacy
Description
We will evaluate health literacy using the Health Literacy Questionnaire (HLQ)
Time Frame
6 months
Title
Health communication
Description
We will evaluate health communication using the Health Literacy Questionnaire (HLQ)
Time Frame
3 months
Title
Health communication
Description
We will evaluate health communication using the Health Literacy Questionnaire (HLQ)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kent D Key, PhD
Phone
810-600-5663
Email
keykent@msu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmine M Hall, MS
Phone
810-600-9191
Email
halljas1@msu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent D Key, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan State University
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kent D Key, PhD
Phone
810-600-5663
Email
keykent@msu.edu
First Name & Middle Initial & Last Name & Degree
Kent D Key, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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