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

Sponsored by:	National Institute of Nursing Research (NINR)
Information provided by:	National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:	NCT00075140

Purpose

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).

Condition	Intervention	Phase
Huntington Disease	Genetic: Mutation in the gene	Phase III

Genetics Home Reference related topics: chorea-acanthocytosis familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease Hurricanes

U.S. FDA Resources

Study Type:	Observational
Official Title:	Family Health After Predictive Huntington Disease Testing

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	422
Study Start Date:	September 2001
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 All Participants hav a family member with Huntington Disease	Genetic: Mutation in the gene

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Family members or significant others, age 14 or older, of persons who 1) have received a positive result from predictive testing for a mutation in the HD gene, 2) are symptomatic and living at home, and 3) are symptomatic and are living in a long-term care institution were the population of interest for this study.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075140

Locations

United States, Iowa
The University of Iowa College of Nursing
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:

Janet K Williams, PhD, RN, FAAN

University of Iowa

More Information

Responsible Party:	University of Iowa ( Janet K. Williams, PhD, RN, FAAN )
Study ID Numbers:	1-R01-NR007970-01
Study First Received:	January 2, 2004
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00075140
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):

Patient Care Management
Family
Huntington's Disease

Study placed in the following topic categories:

Ganglion Cysts
Huntington disease
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders
Chorea

Delirium, Dementia, Amnestic, Cognitive Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Movement Disorders
Dementia
Huntington Disease
Delirium

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009