Hereditary DiseasesFHHNCT05358964
Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the Black Community
A study testing African American Family Health History Education Program in people with Hereditary Diseases, run by Michigan State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Diseases
- What is being tested?
- African American Family Health History Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self Identify as African American; age 18 and older, English speaking
Who cannot join
- Non English speaking, non African American, younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hereditary Diseases
- Being tested
- African American Family Health History Education Program
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
African American Family Health History Education ProgramBehavioural
Also called AAFHHEP
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.
| Study group | Role | What they receive |
|---|---|---|
| African American Family Health History Education Program | Experimental | 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. Receives: Behavioral: African American Family Health History Education Program |
| Genetic Alliance: Does it run in the family | Active comparator | 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. Receives: Behavioral: African American Family Health History Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
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
Measured: 3 months
Quality of Family Health History Discussions
We will evaluate the quality of conversations using the Genetic Alliance Assessment
Measured: 3 months
Quality of Family Health History Discussions
We will evaluate the quality of conversations using the Genetic Alliance Assessment
Measured: 6 months
Acceptability: End of Intervention/Treatment Questionnaire
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Measured: 3 months
Acceptability: End of Intervention/Treatment Questionnaire
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Measured: 6 months
Feasibility: End of Intervention/Treatment Questionnaire
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Measured: 3 months
Feasibility: End of Intervention/Treatment Questionnaire
End of Intervention/Treatment Questionnaire: This is a descriptive measure, positive experiences described meaning higher acceptability
Measured: 6 months
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Measured: 3 months
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Measured: 6 months
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Measured: 3 months
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Measured: 6 months
Secondary outcomes (6)
Satisfaction with Family Health History
We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)
Measured: 3 months
Satisfaction with Family Health History
We will evaluate satisfaction using the the Client Satisfaction Questionnaire (CSQ-8-R)
Measured: 6 months
Understandability
We will evaluate understandability using the Health Literacy Questionnaire (HLQ)
Measured: 3 months
Understandability
We will evaluate understandability using the Health Literacy Questionnaire (HLQ)
Measured: 6 months
Number of screenings requested
We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)
Measured: 3 months
Number of screenings requested
We will evaluate number of screenings requested using the Family Health Communication Quotient (FHCQ)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start30 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kent Key, Michigan State University
- Investigators
- Kent D Key, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358964
- Sponsor's protocol ID
- 00005570
- Acronym
- FHH
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share individual participant data with other researchers. Will will only share data results and summarized data via presentations and manuscript publications.
Publications
Key KD, Lewis L, Blanchard C, Sikorskii A, Patel M, Lucas T, Henry Akintobi T, Bailey S, Loney EH, Johnson JE. Study protocol: Exploring the use of Family Health Histories in the African American community to reduce health disparities in Flint, Michigan. Res Sq [Preprint]. 2024 Apr 1:rs.3.rs-4131949. doi: 10.21203/rs.3.rs-4131949/v1.
PubMed 38645135
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Health Histories: Creating a Culturally Tailored Tool to Reduce Health Disparities in the African American Community
- ClinicalTrials.gov ID
- NCT05358964
- Acronym / sponsor ID
- FHH / 00005570
- Conditions
- Hereditary Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| African American Family Health History Education Program | Experimental | Behavioral: African American Family Health History Education ProgramThe 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. |
| Genetic Alliance: Does it run in the family | Active comparator | Behavioral: African American Family Health History Education ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self Identify as African American; age 18 and older, English speaking
Key exclusion criteria (1 listed)
- Non English speaking, non African American, younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| African American Family Health History Education ProgramAlso: AAFHHEPThe 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. | Behavioural | African American Family Health History Education Program, Genetic Alliance: Does it run in the family |
Primary outcome
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
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
Quality of Family Health History Discussions
Time frame: 3 months
We will evaluate the quality of conversations using the Genetic Alliance Assessment
Quality of Family Health History Discussions
Time frame: 6 months
We will evaluate the quality of conversations using the Genetic Alliance Assessment
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
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
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
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
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
Time frame: 3 months
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)
Time frame: 6 months
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)
Time frame: 3 months
CSQ-8-R: scores range from 8-32, higher scores indicating higher satisfaction
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 secondary outcomes
Satisfaction with Family Health History
Time frame: 3 months
Satisfaction with Family Health History
Time frame: 6 months
Understandability
Time frame: 3 months
Understandability
Time frame: 6 months
Number of screenings requested
Time frame: 3 months
Number of screenings requested
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 38645135Key KD, Lewis L, Blanchard C, Sikorskii A, Patel M, Lucas T, Henry Akintobi T, Bailey S, Loney EH, Johnson JE. Study protocol: Exploring the use of Family Health Histories in the African American community to reduce health disparities in Flint, Michigan. Res Sq [Preprint]. 2024 Apr 1:rs.3.rs-4131949. doi: 10.21203/rs.3.rs-4131949/v1.
- Individual participant dataSharing planned: No. We will not share individual participant data with other researchers. Will will only share data results and summarized data via presentations and manuscript publications.
Related trials for Hereditary Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent D Key, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing African American Family Health History Education Program in people with Hereditary Diseases, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Family Health History with Family (time frame: 3 month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.