Family Health After Predictive Huntington Disease (HD) Testing

Huntington Disease Clinical Trial

Official title:

Family Health After Predictive Huntington Disease Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075140
• Other study ID #: 1R01NR007970-01
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2004
• Last updated: January 15, 2009
• Start date: September 2001
• Est. completion date: October 2008

Study information

• Verified date: January 2009
• Source: National Institute of Nursing Research (NINR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to identify health management concerns and needs of family members of asymptomatic and symptomatic persons with mutation in the gene for Huntington Disease (HD).

Description:

This is an observational study with three phases. In Phase 1, focus groups consisting of family members of persons with HD Gene mutation will be conducted and data collected to be analyzed through content analysis to identify salient themes and key issues. In Phase 2, a survey instrument will be developed and field-tested in order to describe the health care needs, management strategies, and needs for health and social services of relative/significant others of asymptomatic and symptomatic persons with the mutation in the gene for HD.

In Phase 3, the survey will be distributed to family members of asymptomatic and symptomatic persons with mutation in the gene for HD and frequencies and comparisons of survey responses according to respondent characteristics will be reported.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• Family members of asymptomatic and symptomatic persons with mutation in the gene for Huntington Disease

Study Design

N/A

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Genetic:
• Mutation in the gene

Locations

Country	Name	City	State
United States	The University of Iowa College of Nursing	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of a positive HD test or presence of HD on a family members perceptions of: health problems, emotional and functional health status, resources/strategies for managing problems, helpfulness, and services needed to help family members cope.		Over 6 yr span	No
Secondary	Describe the health care needs, management strategies, and needs for health and social services of a broader sample of relatives/significant others in families in which a person has a gene mutation for HD.		Over 6 yr span	No