Caregiver of Huntington's Disease PatientPHRI-HDNCT02876445
Caregiver Burden in Huntington's Disease
A study testing ZARIT Burden Interview in people with Caregiver of Huntington's Disease Patient, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver of Huntington's Disease Patient
- What is being tested?
- ZARIT Burden Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Primary caregiver of patient with Huntington's disease
- Non- institutionalized Patient
- stage 1-4 (no institutionalization within 2 years)
- written consent
Who cannot join
- Not agreement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- ZARIT Burden Interview
- Keywords
- Huntington's disease, Caregiver, ZARIT burden scale
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZARIT Burden InterviewOther
ZARIT Burden Interview completed Day 0 and 1 year
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Evaluation | Other | ZARIT Burden Interview Receives: Other: ZARIT Burden Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation with ZARIT's scale of the burden level of the management of a patient with Huntington's disease by his caregiver
Measured: 1 year
Secondary outcomes (2)
Measuring social impact of the disease using the under score of ZARIT's scale for the patient and the caregiver
Measured: 1 year
Measuring professional impact of of the disease using the under score of ZARIT's scale for the patient and the caregiver
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startMar 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver of Huntington's Disease PatientStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Laure BOURHIS, Senior Health Manager, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876445
- Sponsor's protocol ID
- NI10059
- Acronym
- PHRI-HD
- Status last verified
- Jul 2016
- First submitted
- 31 Jul 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Youssov K, Audureau E, Vandendriessche H, Morgado G, Layese R, Goizet C, Verny C, Bourhis ML, Bachoud-Levi AC. The burden of Huntington's disease: A prospective longitudinal study of patient/caregiver pairs. Parkinsonism Relat Disord. 2022 Oct;103:77-84. doi: 10.1016/j.parkreldis.2022.08.023. Epub 2022 Aug 24.
PubMed 36084356
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Study on Family Burden in Overall Care of Patient With Huntington Disease
- ClinicalTrials.gov ID
- NCT02876445
- Acronym / sponsor ID
- PHRI-HD / NI10059
- Keywords
- Huntington's disease, Caregiver, ZARIT burden scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver Evaluation | Other | Other: ZARIT Burden InterviewZARIT Burden Interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Primary caregiver of patient with Huntington's disease
- Non- institutionalized Patient
- stage 1-4 (no institutionalization within 2 years)
- written consent
Key exclusion criteria (1 listed)
- Not agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZARIT Burden InterviewZARIT Burden Interview completed Day 0 and 1 year | Other | Caregiver Evaluation |
Primary outcome
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
2 secondary outcomes
Measuring social impact of the disease using the under score of ZARIT's scale for the patient and the caregiver
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Derived from this study: PubMed 36084356Youssov K, Audureau E, Vandendriessche H, Morgado G, Layese R, Goizet C, Verny C, Bourhis ML, Bachoud-Levi AC. The burden of Huntington's disease: A prospective longitudinal study of patient/caregiver pairs. Parkinsonism Relat Disord. 2022 Oct;103:77-84. doi: 10.1016/j.parkreldis.2022.08.023. Epub 2022 Aug 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Laure BOURHIS, Senior Health Manager principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZARIT Burden Interview in people with Caregiver of Huntington's Disease Patient, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02876445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.