PolyhandicapPolyMiMeNCT04492761
Family Impact of Polyhandicap: a Mixed Methodological Approach
An observational study of Polyhandicap, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. Read more about this study
- Who is it for?
- Ages 8 to 35 years
- Conditions the study is for
- Polyhandicap
- What is being tested?
- qualitative study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 1 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 8 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: - family member (parent, siblings, uncle / aunt) of a person with a severe multiple disability whose age is between 8 and 35 years old
Who may be able to join
- Familial caregivers: member of a family of a polyhandicapped person aged from 8 to 35 years old
- Patients: with severe polyhandicap defined by the combination of motor deficiency and intellectual impairment associated with everyday life dependence, restricted mobility and age at onset of cerebral lesion below 3 years old
- Written consent signed by caregivers for participation
Who cannot join
- caregivers refusing to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpiatuix de Marseille
Marseille, 13354
Karine BAUMSTARCK, 04 91 32 44 59, karine.baumstarck@univ-amu.fr
About this study
Official title: Family Impact of Polyhandicap: Mixed Methodological Approach
Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. In a preliminary work, we demonstrated that French families reporteda deterioration of the quality of life. This first study, based on a cross-sectional study and quantitative methods, did not allow to explore: 1) the dynamic aspect and the evolution over time of this experience, 2) the mechanisms underlying the difficulties encountered, the needs and expectations of families
- Conditions
- Polyhandicap
- Being tested
- qualitative study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative studyBehavioural
The qualitative approach will be based on content analysis of - Isemi-structured nterviews of families
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualite of life
WHOQOL-Bref
Measured: 5 years
Secondary outcomes (1)
interview content
semi-structured interviews
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyhandicapStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Olivier ARNAUD, Study director, Assistance Publique Hôpitauix de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492761
- Sponsor's protocol ID
- 2019-53
- Acronym
- PolyMiMe
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 30 Jul 2020
- 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 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Impact of Polyhandicap: Mixed Methodological Approach
- ClinicalTrials.gov ID
- NCT04492761
- Acronym / sponsor ID
- PolyMiMe / 2019-53
- Conditions
- Polyhandicap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 30 Jul 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.
Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. In a preliminary work, we demonstrated that French families reporteda deterioration of the quality of life. This first study, based on a cross-sectional study and quantitative methods, did not allow to explore: 1) the dynamic aspect and the evolution over time of this experience, 2) the mechanisms underlying the difficulties encountered, the needs and expectations of families
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- - family member (parent, siblings, uncle / aunt) of a person with a severe multiple disability whose age is between 8 and 35 years old
Key inclusion criteria (3 listed)
- Familial caregivers: member of a family of a polyhandicapped person aged from 8 to 35 years old
- Patients: with severe polyhandicap defined by the combination of motor deficiency and intellectual impairment associated with everyday life dependence, restricted mobility and age at onset of cerebral lesion below 3 years old
- Written consent signed by caregivers for participation
Key exclusion criteria (1 listed)
- caregivers refusing to participate
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 |
|---|---|---|
| qualitative studyThe qualitative approach will be based on content analysis of - Isemi-structured nterviews of families | Behavioural | – |
Primary outcome
Qualite of life
Time frame: 5 years
WHOQOL-Bref
1 secondary outcome
interview content
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
Related trials for Polyhandicap
RecruitingObservational study
Third Wave of the EVAL-PLH (POLYhandicap) Cohort: New Eyes
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Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities
Respiratory Decompensation, Multiple Disabilities
Recruiting
Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
Polyhandicap
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.
Jean Olivier ARNAUD study director
Assistance Publique Hôpitauix de Marseille
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 Polyhandicap, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karine Baumstarck (04 91 32 44 59, karine.baumstarck@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualite of life (time frame: 5 years). 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 30 Jul 2020.