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Status unknownNCT04492761PolyMiMeUpdated Jul 30, 2020

Family Impact of Polyhandicap: a Mixed Methodological Approach

An observational study in Polyhandicap, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 8 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
8 Years to 35 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Polyhandicap
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 146 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • caregivers refusing to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
260 participants (estimated)
Patient registry
No

Interventions

  • Behavioralqualitative study

    The qualitative approach will be based on content analysis of - Isemi-structured nterviews of families

06

What researchers measure

Primary outcomes

  1. Qualite of life

    WHOQOL-Bref

    Time frame: 5 years

Secondary outcomes

  1. interview content

    semi-structured interviews

    Time frame: 2 hours

07

Study locations

1 of 1 sites recruiting
  • Assistance Publique Hôpiatuix de Marseille
    Marseille, 13354, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04492761
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jul 30, 2020
Start date
Jun 1, 2020
Primary completion
Jun 1, 2021 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Jul 30, 2020

Study contacts

Karine Baumstarck
Contact
karine.baumstarck@univ-amu.fr
04 91 32 44 59
Jean Olivier ARNAUD
study director · Assistance Publique Hôpitauix de Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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