- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05358964
Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the Black Community (FHH)
Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the African American Community
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kent D Key, PhD
- Phone Number: 810-600-5663
- Email: keykent@msu.edu
Study Contact Backup
- Name: Jasmine M Hall, MS
- Phone Number: 810-600-9191
- Email: halljas1@msu.edu
Study Locations
-
-
Michigan
-
Flint, Michigan, United States, 48502
- Recruiting
- Michigan State University
-
Principal Investigator:
- Kent D Key, PhD
-
Contact:
- Kent D Key, PhD
- Phone Number: 8106005663
- Email: keykent@msu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
|
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:
|
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
Sponsor
Investigators
- Principal Investigator: Kent D Key, PhD, Michigan State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00005570
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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