Quality of LifeCOMPQUAHDNCT04411238
Skills of Home Helpers for a Better Quality of Life for Adults With Huntington's Disease Living at Home
An observational study of Quality of Life, run by University Hospital, Angers.
Trial summary
Huntington's disease often brings together 3 types of symptoms at one time or another of the disease during its evolution: motor, cognitive and psychiatric. Management requires comprehensive and multidisciplinary health, social or medico-social support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- interview
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 90 participants, including 30 cases with Huntington's disease, 30 caregivers not concerned himself with the risk of developing the disease and 30 home helper worker for Huntington's disease patients.
Selection Criteria:
Patient group :
- Genetic diagnosis of Huntington's disease
- Symptomatic patient
- Patient living at home
- Person able to carry out the interviews provided for in the study
Caregiver group :
- Person, defined within the meaning of the CNSA (National Solidarity Fund for Autonomy) as a natural caregiver, not concerned himself by the risk of developing the disease
- person able to carry out the interviews provided for in the study
Home Helper group :
- Professionals working at home with Huntington's disease patients employed by home help service providers.
About this study
Huntington's disease often brings together 3 types of symptoms at one time or another of the disease during its evolution: motor, cognitive and psychiatric. Management requires comprehensive and multidisciplinary health, social or medico-social support. Its development generates additional difficulties for professionals who very often qualify this disease as "very complex" because it leads to a deep and severe impairment of physical and intellectual capacities. The sick person gradually loses their autonomy and becomes dependent for the acts of daily life, hence the choice of this disease for our study. Our study is focused on the quality of life at home of patients followed by the Angers Reference Center, "expert" on neurogenetic pathologies.
Studies focusing on patients' quality of life at home have so far never been undertaken for a rare neurodegenerative disease like Huntington's disease.
- Conditions
- Quality of Life
- Being tested
- interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
interview
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: interview | |
| Caregivers | Not described Receives: Other: interview | |
| Home help | Not described Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and compare the expectations and needs of patients with Huntington's disease, their caregivers, and home helpers, in terms of home support, based on interviews
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411238
- Sponsor's protocol ID
- 2020/28
- Acronym
- COMPQUAHD
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills of Home Helpers for a Better Quality of Life for Adults With Huntington's Disease Living at Home
- ClinicalTrials.gov ID
- NCT04411238
- Acronym / sponsor ID
- COMPQUAHD / 2020/28
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 2 Jun 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.
Huntington's disease often brings together 3 types of symptoms at one time or another of the disease during its evolution: motor, cognitive and psychiatric. Management requires comprehensive and multidisciplinary health, social or medico-social support. Its development generates additional difficulties for professionals who very often qualify this disease as "very complex" because it leads to a deep and severe impairment of physical and intellectual capacities. The sick person gradually loses their autonomy and becomes dependent for the acts of daily life, hence the choice of this disease for our study. Our study is focused on the quality of life at home of patients followed by the Angers Reference Center, "expert" on neurogenetic pathologies.
Studies focusing on patients' quality of life at home have so far never been undertaken for a rare neurodegenerative disease like Huntington's disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: interview |
| Caregivers | – | Other: interview |
| Home help | – | Other: interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 90 participants, including 30 cases with Huntington's disease, 30 caregivers not concerned himself with the risk of developing the disease and 30 home helper worker for Huntington's disease patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewinterview | Other | Caregivers, Home help, Patients |
Primary outcome
Identify and compare the expectations and needs of patients with Huntington's disease, their caregivers, and home helpers, in terms of home support, based on interviews
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Identify and compare the expectations and needs of patients with Huntington's disease, their caregivers, and home helpers, in terms of home support, based on interviews (time frame: One day). 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 2 Jun 2020.