Trial record 1 of 1 for:
Cocoon | Huntington’s disease
Couple and Spouse Caregiver in Huntington's Disease (COCOON)
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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. |
| ClinicalTrials.gov Identifier: NCT04394767 |
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Recruitment Status : Unknown
Verified May 2020 by University Hospital, Lille.
Recruitment status was: Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
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Sponsor:
University Hospital, Lille
Information provided by (Responsible Party):
University Hospital, Lille
- Study Details
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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 |
| 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
MedlinePlus Genetics related topics:
Huntington disease
Primary Outcome Measures :
- 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 :
- 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
| Contact: Clémence SIMONIN, MD | 0320445962 ext +33 | clemence.simonin@chru-lille.fr |
Locations
| France | |
| Hôpital Roger Salengro, CHU Lille | Recruiting |
| Lille, France, 59037 | |
| Contact 0320445962 | |
Sponsors and Collaborators
University Hospital, Lille
Investigators
| Principal Investigator: | Clémence Simonin, MD | University Hospital, Lille | |
| Principal Investigator: | Pascal ANTOINE, MD | University Hospital, Lille |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University Hospital, Lille:
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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 Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases |
Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders Dementia Chorea Dyskinesias |