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Couple and Spouse Caregiver in Huntington's Disease (COCOON)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04394767
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
The objectives are to better document the psychosocial status and needs of caregiver of HD patients and understand the dyad functioning, facing the disease at various stages.

Condition or disease
Huntington Disease

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Couple and Spouse Caregiver in Huntington's Disease
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease [ Time Frame: once time, Baseline ]
    Qualitative assessment: Interpretative phenomenological analysis (IPA) by semi-structured interviews to explore families representations and strategies about the patients with Huntington's Disease


Secondary Outcome Measures :
  1. report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease [ Time Frame: once time, Baseline ]
    Qualitative assessment : Thematic analysis by COAT (Carers Outcome Agreement Tool) during a semi-structured interviews to explore families representations and strategies about the patients with Huntington's Disease



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Huntington disease population ( patient, caregiver, spouses)
Criteria

Inclusion Criteria:

For patient :

  • HD, CAG > 36, motor UHDRS > 5
  • Being able to communicate with the investigator

For both spouses :

  • Living together since at least 5 years
  • 30 to 60 years old

Exclusion Criteria:

For patient :

- Other chronic neurologic disorder

For both spouses :

  • Psychiatric disease
  • Unable to participate, incl read, understand and sign the informed consent

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 ClinicalTrials.gov identifier (NCT number): NCT04394767


Contacts
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Contact: Clémence SIMONIN, MD 0320445962 ext +33 clemence.simonin@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHU Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Clémence Simonin, MD University Hospital, Lille
Principal Investigator: Pascal ANTOINE, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04394767    
Other Study ID Numbers: 2018_33
2018-A02046-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Huntington's disease
spouse caregiver
quality of life
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders