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

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.

Study Overview

• Status: Recruiting
• Conditions: Huntington Disease

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Clémence Simonin, MD; Phone Number: +33 0320445962; Email: clemence.simonin@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hôpital Roger Salengro, CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Huntington disease population ( patient, caregiver, spouses)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Clémence Simonin, MD, University Hospital, Lille; Principal Investigator: Pascal ANTOINE, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; Huntington's disease; spouse caregiver
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Dementia; Cognition Disorders; Chorea; Huntington Disease
• Other Study ID Numbers: 2018_33; 2018-A02046-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No