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Trial record 4 of 192 for:    "huntington disease"

Caregiver Burden in Huntington's Disease (PHRI-HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02876445
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Huntington's disease (HD) is a rare inherited neurodegenerative disorder, progressing between 15 and 20 years and affecting one person out of 10.000. In France, it concerns some 6.000 patients symptomatic and 12 000 asymptomatic carriers.

Few extensive researches have been conducted on the progression of the disease, which is defined in the literature in 5 stages in a functional approach.

Therapeutically, no cure for HD is currently validated but only symptomatic treatments. There's various treatment options: medicated, humans (physiotherapy, speech therapist, occupational therapist, ..).

Although these treatment options do not prevent the progression of the disease, their combination associated with a stimulating environment may slow the decline of physical, intellectual and psychic abilities of patients.

In social terms, patients with HD require sustained support, especially in cases of family isolation.

The behavioural, gaiting and eating disorder as well as the communications difficulties make it difficult support daily for the entourage. The caregivers are sometimes dealing with untenable situations. Home care services, which are crucial to alleviating dependency, relieve family caregivers but are for the most severe patient.

Moreover, the justified placement decision in an institution generates a feeling of guilt for the family.

The caregiver is the person who brings non-professional assistance , partly or wholly , to a dependent member of his entourage , for the activities of daily living. This regular care may be provided permanently or not. It can take many forms, such as , care , nursing , support to education and social life , administrative procedures , psychological support .

Caregivers have their lives profoundly reshaped. They are often forced to give up some of their habits , give up their future plans , change their relationships. The commitment of caregivers with patients with Huntington's disease actually sounds on their mental and physical health, as well as their social and professional life

Very few studies have been conducted to measure the difficulties and implications of these caregivers.

Condition or disease Intervention/treatment Phase
Caregiver of Huntington's Disease Patient Other: ZARIT Burden Interview Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Assessment Study on Family Burden in Overall Care of Patient With Huntington Disease
Study Start Date : March 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Caregiver Evaluation
ZARIT Burden Interview
Other: ZARIT Burden Interview
ZARIT Burden Interview completed Day 0 and 1 year

Primary Outcome Measures :
  1. Evaluation with ZARIT's scale of the burden level of the management of a patient with Huntington's disease by his caregiver [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Measuring social impact of the disease using the under score of ZARIT's scale for the patient and the caregiver [ Time Frame: 1 year ]
  2. Measuring professional impact of of the disease using the under score of ZARIT's scale for the patient and the caregiver [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Age ≥ 18
  • Primary caregiver of patient with Huntington's disease
  • Non- institutionalized Patient
  • stage 1-4 (no institutionalization within 2 years)
  • written consent

Exclusion Criteria

- Not agreement

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 identifier (NCT number): NCT02876445

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Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Marie-Laure BOURHIS, Senior Health Manager Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT02876445     History of Changes
Other Study ID Numbers: NI10059
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: July 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Huntington's disease
ZARIT burden scale
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders