Huntington DiseaseCOCOONNCT04394767
Couple and Spouse Caregiver in Huntington's Disease
An observational study of Huntington Disease, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2020to 12 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Huntington disease population ( patient, caregiver, spouses)
Who may be able to join
- 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
Who cannot join
- For patient :
- Other chronic neurologic disorder
- For both spouses :
- Psychiatric disease
- Unable to participate, incl read, understand and sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Huntington Disease
- Keywords
- Huntington's disease, spouse caregiver, quality of life
- Medical subject headings
- Huntington Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: once time, Baseline
Secondary outcomes (1)
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
Measured: once time, Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start13 Jan 2020
- Primary completion12 Jan 2024
- Study completion12 Jan 2025
Why it stopped: Sponsor's decision, no more inclusions made since the last extension
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clémence Simonin, MD, Principal investigator, University Hospital, LillePascal ANTOINE, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394767
- Sponsor's protocol ID
- 2018_33
- Other IDs
- 2018-A02046-49
- Acronym
- COCOON
- Status last verified
- May 2025
- First submitted
- 16 Oct 2019
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couple and Spouse Caregiver in Huntington's Disease
- ClinicalTrials.gov ID
- NCT04394767
- Acronym / sponsor ID
- COCOON / 2018_33
- Conditions
- Huntington Disease
- Keywords
- Huntington's disease, spouse caregiver, quality of life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor's decision, no more inclusions made since the last extension
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2025 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Huntington disease population ( patient, caregiver, spouses)
Key inclusion criteria (6 listed)
- HD, CAG > 36, motor UHDRS > 5
- Being able to communicate with the investigator
- Living together since at least 5 years
- 30 to 60 years old
Key exclusion criteria (5 listed)
- Other chronic neurologic disorder
- Psychiatric disease
- Unable to participate, incl read, understand and sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease
Time frame: once time, Baseline
Results and safety
The study was stopped early (reason given: Sponsor's decision, no more inclusions made since the last extension). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clémence Simonin, MD principal investigator
University Hospital, Lille
Pascal ANTOINE, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision, no more inclusions made since the last extension). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease (time frame: once time, Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.