Family Health After Predictive Huntington Disease (HD) Testing
| Tracking Information | |||||
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| 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 | Not Provided | ||||
| 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 | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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). |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Huntington Disease | ||||
| Intervention ICMJE | Genetic: Mutation in the gene | ||||
| Study Group/Cohort (s) | 1
All Participants hav a family member with Huntington Disease
Intervention: Genetic: Mutation in the gene |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| 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 |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00075140 | ||||
| Other Study ID Numbers ICMJE | 1-R01-NR007970-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Janet K. Williams, PhD, RN, FAAN, University of Iowa | ||||
| Study Sponsor ICMJE | National Institute of Nursing Research (NINR) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Nursing Research (NINR) | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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