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Family Health After Predictive Huntington Disease (HD) Testing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00075140
First Posted: January 5, 2004
Last Update Posted: January 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Nursing Research (NINR)
  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 3

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

Resource links provided by NLM:


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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Janet K. Williams, PhD, RN, FAAN, University of Iowa
ClinicalTrials.gov Identifier: NCT00075140     History of Changes
Other Study ID Numbers: 1R01NR007970-01 ( U.S. NIH Grant/Contract )
First Submitted: January 2, 2004
First Posted: January 5, 2004
Last Update Posted: January 16, 2009
Last Verified: January 2009

Keywords provided by National Institute of Nursing Research (NINR):
Patient Care Management
Family
Huntington's Disease

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders