Family Health After Predictive Huntington Disease (HD) Testing

January 15, 2009 updated by: National Institute of Nursing Research (NINR)

Family Health After Predictive Huntington Disease Testing

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

422

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University Of Iowa College Of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
All Participants hav a family member with Huntington Disease
Genetic: Mutation in the gene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Over 6 yr span

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Over 6 yr span

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Janet K Williams, PhD, RN, FAAN, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 2, 2004

First Submitted That Met QC Criteria

January 2, 2004

First Posted (Estimate)

January 5, 2004

Study Record Updates

Last Update Posted (Estimate)

January 16, 2009

Last Update Submitted That Met QC Criteria

January 15, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01NR007970-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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