Family Health After Predictive Huntington Disease (HD) Testing

Completed

• Conditions: Huntington Disease
• Interventions: Genetic: Mutation in the gene

• Registration Number: NCT00075140
• Lead Sponsor: National Institute of Nursing Research (NINR)

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2004-01-02
• Study First Submitted QC: 2004-01-02
• Study First Posted: 2004-01-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-15
• Last Update Posted: 2009-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Mutation in the gene	All Participants hav a family member with Huntington Disease

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Iowa College of Nursing; 🇺🇸 Iowa City, Iowa, United States