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Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience (HUNTEXPERT)

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ClinicalTrials.gov Identifier: NCT02218567
Recruitment Status : Unknown
Verified June 2014 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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 the adaptation to behavioural problems of Huntington Disease patients.

Condition or disease Intervention/treatment Phase
Huntington Disease Behavioral: questionnaire qualilty of life Behavioral: psychological interview Behavioral: psychological tests Other: Motor evaluation Behavioral: Behavioral evaluation Behavioral: cognitive tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : June 2014
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients Behavioral: psychological interview
Behavioral: psychological tests
Other: Motor evaluation
Behavioral: Behavioral evaluation
Behavioral: cognitive tests
Caregivers Behavioral: questionnaire qualilty of life
Behavioral: psychological interview



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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
    • Subject gave its written consent
  • For caregivers :

    • No risk of caregiver having Huntington disease
    • Aged 18 years and above
    • Subject gave its written consent

Exclusion Criteria:

  • 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

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): NCT02218567


Contacts
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Contact: Philippe ALLAIN, Pr. PhAllain@chu-angers.fr

Locations
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France
University Hospital of Angers Recruiting
Angers, Maine et Loire, France, 49933
Contact: Philippe ALLAIN, Pr.       Ph.Allain@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02218567     History of Changes
Other Study ID Numbers: 2014-A00327-40
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
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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