Family Impact of Polyhandicap: a Mixed Methodological Approach (PolyMiMe)

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

Study Overview

• Status: Unknown
• Conditions: Polyhandicap
• Intervention / Treatment: Behavioral: qualitative study

• Study Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

• Study Contact: Name: Karine BAUMSTARCK; Phone Number: 04 91 32 44 59; Email: karine.baumstarck@univ-amu.fr

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hôpiatuix de Marseille
    • Contact: Karine BAUMSTARCK; Phone Number: 04 91 32 44 59; Email: karine.baumstarck@univ-amu.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualite of life	WHOQOL-Bref	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interview content	semi-structured interviews	2 hours

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Jean Olivier ARNAUD, Assistance Publique Hôpitauix de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-53

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No