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

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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

Tracking Information
First Submitted Date October 16, 2019
First Posted Date May 19, 2020
Last Update Posted Date May 19, 2020
Actual Study Start Date January 13, 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 14, 2020)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Couple and Spouse Caregiver in Huntington's Disease
Official Title Couple and Spouse Caregiver in Huntington's Disease
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Huntington disease population ( patient, caregiver, spouses)
Condition Huntington Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 14, 2020)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Clémence SIMONIN, MD 0320445962 ext +33 clemence.simonin@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04394767
Other Study ID Numbers 2018_33
2018-A02046-49 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Clémence Simonin, MD University Hospital, Lille
Principal Investigator: Pascal ANTOINE, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date May 2020