NCT05358964

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
2.9 years until next milestone

Study Start

First participant enrolled

March 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

March 14, 2022

Last Update Submit

September 8, 2025

Conditions

Hereditary Diseases

Outcome Measures

Primary Outcomes (12)

  • 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

    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

    3 months

  • Quality of Family Health History Discussions

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

    3 months

  • Quality of Family Health History Discussions

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

    6 months

  • Acceptability: End of Intervention/Treatment Questionnaire

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

    3 months

  • Acceptability: End of Intervention/Treatment Questionnaire

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

    6 months

  • Feasibility: End of Intervention/Treatment Questionnaire

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

    3 months

  • Feasibility: End of Intervention/Treatment Questionnaire

    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)

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

    3 months

  • Acceptability: Client Satisfaction Questionnaire (CSQ-8-R)

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

    6 months

  • Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)

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

    3 months

  • Feasibility: Client Satisfaction Questionnaire (CSQ-8-R)

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

    6 months

Secondary Outcomes (6)

  • Satisfaction with Family Health History

    3 months

  • Satisfaction with Family Health History

    6 months

  • Understandability

    3 months

  • Understandability

    6 months

  • Number of screenings requested

    3 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Health literacy

    3 months

  • Health literacy

    6 months

  • Health communication

    3 months

  • +1 more other outcomes

Study Arms (2)

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.

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.

Behavioral: African American Family Health History Education Program

Interventions

African American Family Health History Education ProgramBEHAVIORAL

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.

Also known as: AAFHHEP
African American Family Health History Education ProgramGenetic Alliance: Does it run in the family

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self Identify as African American; age 18 and older, English speaking

You may not qualify if:

  • Non English speaking, non African American, younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

Flint, Michigan, 48502, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38645135DERIVED

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kent D Key, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kent D Key, PhD

CONTACT

810-600-5663keykent@msu.edu

Jasmine M Hall, MS

CONTACT

810-600-9191halljas1@msu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 14, 2022

First Posted

May 3, 2022

Study Start

March 30, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)