Caregiver of Huntington's Disease Patient Clinical Trial
— PHRI-HDOfficial title:
Assessment Study on Family Burden in Overall Care of Patient With Huntington Disease
| Verified date | July 2016 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 179 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Henri Mondor Hospital | Creteil |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation with ZARIT's scale of the burden level of the management of a patient with Huntington's disease by his caregiver | 1 year | No | |
| Secondary | Measuring social impact of the disease using the under score of ZARIT's scale for the patient and the caregiver | 1 year | No | |
| Secondary | Measuring professional impact of of the disease using the under score of ZARIT's scale for the patient and the caregiver | 1 year | No |