Family Impact of Polyhandicap: a Mixed Methodological Approach

Polyhandicap Clinical Trial

— PolyMiMe  

Official title:

Family Impact of Polyhandicap: Mixed Methodological Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492761
• Other study ID #: 2019-53
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2020
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Karine Baumstarck
• Phone: 04 91 32 44 59
• Email: karine.baumstarck[@]univ-amu.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 35 Years

Eligibility

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:

• caregivers refusing to participate

Related Conditions & MeSH terms

• Polyhandicap

Intervention

Behavioral:
• qualitative study
The qualitative approach will be based on content analysis of - Isemi-structured nterviews of families

Locations

Country	Name	City	State
France	Assistance Publique Hôpiatuix de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualite of life	WHOQOL-Bref	5 years
Secondary	interview content	semi-structured interviews	2 hours