Huntington DiseaseHUNTEXPERTNCT02218567
Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience
A study testing questionnaire qualilty of life, psychological interview and psychological tests in people with Huntington Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The study hypothesis is that caregivers experience allows them to develop a lot of knowledge and know-how about behavioural problems in Huntington Disease and its consequences. The purpose of this study is to collect, describe and analyse caregivers experience in order to find and enhance their knowledge related to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- questionnaire qualilty of life, psychological interview and psychological tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients:
- Patients with Huntington Disease declared
- Huntington Disease diagnosed with abnormal number of CAG repeats: 38 < nucleotide expansion (CAG)
- Total Functional Capacity ≥ 7
- Patients living with a caregiver
- Aged 18 years and above
Show all 11Show fewer
- Subject gave its written consent
- For caregivers :
- No risk of caregiver having Huntington disease
- Aged 18 years and above
- Subject gave its written consent
Who cannot join
- For patients:
- Patient who do not live with a caregiver
- No national health insurance affiliation
- Being under guardianship
- For caregivers :
- Caregiver at risk for Huntington Disease
- No national health insurance affiliation
- Being under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The study hypothesis is that caregivers experience allows them to develop a lot of knowledge and know-how about behavioural problems in Huntington Disease and its consequences. The purpose of this study is to collect, describe and analyse caregivers experience in order to find and enhance their knowledge related to the adaptation to behavioural problems of Huntington Disease patients.
- Conditions
- Huntington Disease
- Being tested
- questionnaire qualilty of life, psychological interview, psychological tests, Motor evaluation, Behavioral evaluation
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire qualilty of lifeBehavioural
psychological interviewBehavioural
psychological testsBehavioural
Motor evaluationOther
Behavioral evaluationBehavioural
cognitive testsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Not described Receives: Behavioral: psychological interview; Behavioral: psychological tests; Other: Motor evaluation; Behavioral: Behavioral evaluation; Behavioral: cognitive tests |
| Caregivers | Other | Not described Receives: Behavioral: questionnaire qualilty of life; Behavioral: psychological interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Huntington's Disease health-related Quality of Life questionnaire
The primary outcome is to find a list of caregiver competences necessary to prevent and adapt to behavioural problems of Huntington Disease patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: inclusion difficult
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.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218567
- Sponsor's protocol ID
- 2014-A00327-40
- Acronym
- HUNTEXPERT
- Status last verified
- Jun 2014
- First submitted
- 14 Aug 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience
- ClinicalTrials.gov ID
- NCT02218567
- Acronym / sponsor ID
- HUNTEXPERT / 2014-A00327-40
- Conditions
- Huntington Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficult
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Aug 2014 (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 study hypothesis is that caregivers experience allows them to develop a lot of knowledge and know-how about behavioural problems in Huntington Disease and its consequences. The purpose of this study is to collect, describe and analyse caregivers experience in order to find and enhance their knowledge related to the adaptation to behavioural problems of Huntington Disease patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Behavioral: psychological interview, Behavioral: psychological tests, Other: Motor evaluation, Behavioral: Behavioral evaluation, Behavioral: cognitive tests |
| Caregivers | Other | Behavioral: questionnaire qualilty of life, Behavioral: psychological interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For patients:
- For caregivers :
Key exclusion criteria (8 listed)
- For patients:
- For caregivers :
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 |
|---|---|---|
| questionnaire qualilty of life | Behavioural | Caregivers |
| psychological interview | Behavioural | Caregivers, Patients |
| psychological tests | Behavioural | Patients |
| Motor evaluation | Other | Patients |
| Behavioral evaluation | Behavioural | Patients |
| cognitive tests | Behavioural | Patients |
Primary outcome
The Huntington's Disease health-related Quality of Life questionnaire
Time frame: Baseline
The primary outcome is to find a list of caregiver competences necessary to prevent and adapt to behavioural problems of Huntington Disease patients.
Results and safety
The study was stopped early (reason given: inclusion difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire qualilty of life, psychological interview and psychological tests in people with Huntington Disease, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. 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 France. 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 was stopped early (reason given: inclusion difficult). Results are not available in the source record.
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?
The Huntington's Disease health-related Quality of Life questionnaire (time frame: Baseline). 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 22 Oct 2020.