Huntington DiseaseNCT00075140
Family Health After Predictive Huntington Disease (HD) Testing
An observational study of Huntington Disease, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Mutation in the gene
- How many people
- 422 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
- Family members of asymptomatic and symptomatic persons with mutation in the gene for Huntington Disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa College of Nursing
Iowa City, Iowa, 52242
About this study
Official title: 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).
Read the 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.
- Conditions
- Huntington Disease
- Being tested
- Mutation in the gene
- Keywords
- Patient Care Management, Family, Huntington's Disease
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mutation in the geneGenetic
| Study group | Role | What they receive |
|---|---|---|
| 1 | All Participants hav a family member with Huntington Disease Receives: Genetic: Mutation in the gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over 6 yr span
Secondary outcomes (1)
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.
Measured: Over 6 yr span
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2004 (estimated)
- Study startSep 2001
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Janet K Williams, PhD, RN, FAAN, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075140
- Sponsor's protocol ID
- 1R01NR007970-01
- Status last verified
- Jan 2009
- First submitted
- 2 Jan 2004
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Health After Predictive Huntington Disease Testing
- ClinicalTrials.gov ID
- NCT00075140
- Acronym / sponsor ID
- 1R01NR007970-01
- Conditions
- Huntington Disease
- Keywords
- Patient Care Management, Family, Huntington's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Sep 2001
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Genetic: Mutation in the geneAll Participants hav a family member with Huntington Disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mutation in the gene | Genetic | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet K Williams, PhD, RN, FAAN principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2009.