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

October 20, 2020 updated by: University Hospital, Angers
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Maine Et Loire
      • Angers, Maine Et Loire, France, 49933
        • University hospital of Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00327-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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