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

August 18, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Assessment Study on Family Burden in Overall Care of Patient With Huntington Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

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
      • Creteil, France, 94010
        • Henri Mondor Hospital

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

Yes

Genders Eligible for Study

All

Description

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

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Measuring social impact of the disease using the under score of ZARIT's scale for the patient and the caregiver
Time Frame: 1 year
1 year
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
1 year

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marie-Laure BOURHIS, Senior Health Manager, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI10059

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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