Family Impact of Polyhandicap: a Mixed Methodological Approach

NCT04492761 | Unknown

• 1 other identifier: 2019-53
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Polyhandicap

Outcome Measures

Primary Outcomes (1)

• Qualite of life

  WHOQOL-Bref

  5 years

Secondary Outcomes (1)

• interview content

  2 hours

Interventions

qualitative study BEHAVIORAL

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

Eligibility Criteria

• Age: 8 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• caregivers refusing to participate

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpiatuix de Marseille

Marseille, 13354, France

RECRUITING

Study Officials

• Jean Olivier ARNAUD

  Assistance Publique Hôpitauix de Marseille

  STUDY DIRECTOR

Central Study Contacts

Karine Baumstarck

CONTACT

04 91 32 44 59; karine.baumstarck@univ-amu.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

FR (1)