Family Health After Predictive Huntington Disease (HD) Testing - Tabular View

Tracking Information

First Received Date ^ICMJE

January 2, 2004

Last Updated Date

January 15, 2009

Start Date ^ICMJE

September 2001

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: Over 6 yr span ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00075140 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: Over 6 yr span ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Family Health After Predictive Huntington Disease (HD) Testing

Official Title ^ICMJE

Family Health After Predictive Huntington Disease Testing

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 Phase

Phase III

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other, Other

Condition ^ICMJE

Huntington Disease

Intervention ^ICMJE

Genetic: Mutation in the gene

Study Arms / Comparison Groups

All Participants hav a family member with Huntington Disease

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

422

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00075140

Responsible Party

Janet K. Williams, PhD, RN, FAAN, University of Iowa

Study ID Numbers ^ICMJE

1-R01-NR007970-01

Study Sponsor ^ICMJE

National Institute of Nursing Research (NINR)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Janet K Williams, PhD, RN, FAAN

University of Iowa

Information Provided By

National Institute of Nursing Research (NINR)

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP