NCT00441077

Brief Summary

This study will examine how to communicate with an underserved population about inherited disease risks. It will present information about inherited risk to a Latino population through either a lay health advisor (LHA) or through printed information. The LHA is a member of the Latino community who has received training in public speaking, group facilitation, and managing group dynamics and in family health history and genetics. Previous studies have shown that an LHA can effectively communicate health information to diverse audiences, but such interventions have not been studied in the context of inherited risk. Spanish-speaking Latino men and women over the age of 18 in the Oakland, CA, and Washington, DC, areas who have basic Spanish reading and writing skills may be eligible for this study. Participants are recruited to one of two groups. One group participates in group educational sessions with an LHA about inherited disease risks and family health history, and the other receives this information from a brochure. Educational Sessions Groups of 5 to 8 individuals complete a questionnaire and then participate in a 45-minute educational session on concepts related to genetics, family health history, lifestyle and environment. Participants engage in role-playing to practice discussing family health history with family members. The LHA teaches participants the skills needed to fill in family health history tool called My Family Health Portrait and answers questions. After the question and answer session, participants complete a second questionnaire. Brochure-Only Participants complete a questionnaire and then read a Spanish-language brochure produced by the U.S. Surgeon General's Office about the importance of knowing one's family history. They then complete a second questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

February 19, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2007

Completed
Last Updated

July 2, 2017

Status Verified

August 25, 2009

Enrollment Period

10 months

First QC Date

February 27, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

GeneticsFamily HistoryLatinoInformation SeekingLay Health AdvisorsCancerHeart DiseaseDiabetesInformation

Outcome Measures

Primary Outcomes (1)

  • Intentions to seek information about family history.

Interventions

EducationBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • All participants in this study will be healthy volunteers. Eligibility criteria for participation in the study are the following: (1) being at least 18 years of age; and (2) being able to speak Spanish and having basic Spanish reading and writing skills.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

La Raza

Oakland, California, United States

Location

La Clinica del Pueblo

Washington D.C., District of Columbia, 20009, United States

Location

Related Publications (3)

  • Balcazar H, Alvarado M, Hollen ML, Gonzalez-Cruz Y, Pedregon V. Evaluation of Salud Para Su Corazon (Health for your Heart) -- National Council of La Raza Promotora Outreach Program. Prev Chronic Dis. 2005 Jul;2(3):A09. Epub 2005 Jun 15.

    PMID: 15963311BACKGROUND
  • Catz DS, Green NS, Tobin JN, Lloyd-Puryear MA, Kyler P, Umemoto A, Cernoch J, Brown R, Wolman F. Attitudes about genetics in underserved, culturally diverse populations. Community Genet. 2005;8(3):161-72. doi: 10.1159/000086759.

    PMID: 16113533BACKGROUND
  • Derose KP, Baker DW. Limited English proficiency and Latinos' use of physician services. Med Care Res Rev. 2000 Mar;57(1):76-91. doi: 10.1177/107755870005700105.

    PMID: 10705703BACKGROUND

MeSH Terms

Conditions

NeoplasmsHeart DiseasesDiabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

February 27, 2007

First Posted

February 28, 2007

Study Start

February 19, 2007

Primary Completion

December 12, 2007

Study Completion

December 12, 2007

Last Updated

July 2, 2017

Record last verified: 2009-08-25

Locations