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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04394767
Other study ID # 2018_33
Secondary ID 2018-A02046-49
Status Recruiting
Phase
First received
Last updated
Start date January 13, 2020
Est. completion date February 2025

Study information

Verified date October 2022
Source University Hospital, Lille
Contact Clémence SIMONIN, MD
Phone 0320445962
Email clemence.simonin@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Roger Salengro, CHU Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease Qualitative assessment: Interpretative phenomenological analysis (IPA) by semi-structured interviews to explore families representations and strategies about the patients with Huntington's Disease once time, Baseline
Secondary report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease 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 once time, Baseline
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