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

Primary Purpose

Huntington Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaire qualilty of life
psychological interview
psychological tests
Motor evaluation
Behavioral evaluation
cognitive tests
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Huntington Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients

Caregivers

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2014
Last Updated
October 20, 2020
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02218567
Brief Title
Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience
Acronym
HUNTEXPERT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
inclusion difficult
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Arm Title
Caregivers
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
questionnaire qualilty of life
Intervention Type
Behavioral
Intervention Name(s)
psychological interview
Intervention Type
Behavioral
Intervention Name(s)
psychological tests
Intervention Type
Other
Intervention Name(s)
Motor evaluation
Intervention Type
Behavioral
Intervention Name(s)
Behavioral evaluation
Intervention Type
Behavioral
Intervention Name(s)
cognitive tests
Primary Outcome Measure Information:
Title
The Huntington's Disease health-related Quality of Life questionnaire
Description
The primary outcome is to find a list of caregiver competences necessary to prevent and adapt to behavioural problems of Huntington Disease patients.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University Hospital of Angers
City
Angers
State/Province
Maine Et Loire
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

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

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