Prospective Cohort Follow-up of French Patients With Profound and Multiple Disabilities: Healthcare Pathways and Quality of Life Among Patients and Their Families

Not Applicable

• Conditions: Paraparesis; Tetraparesis; Hemiparesis; Ataxia; Neuromuscular Disorders; Extrapyramidal Motor Disorders
• Interventions: Behavioral: quality of life questionnaires

• Registration Number: NCT02400528
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

The studies conducted so far concerning the medical and paramedical cares provided to patients with profound and multiple disabilities (PMD) often show important limitations: samples are too small or very heterogeneous, generally constituted of children only; studies are mainly cross-sectional and retrospective, focusing on very specific issues instead of assessing health and quality of life from a more global perspective... So far, the investigators found no published data from a prospective cohort study involving a representative sample of patients with PMD. The present project aims to set up such a cohort so as to describe for the first time the natural history of French patients with PMD as well as the cares they receive at home or within the different dedicated structures in France. This cohort will also make it possible to identify the factors responsible for differences in the cares patients are provided, the consequences of these differences on their health and their quality of life (and those of their relatives) as well as the evolutions of these data over time. It will then allow for assessing the effectiveness of the French healthcare system to care for patients with PMD as well as building a frame of reference regarding the best cares to provide to these patients.

The primary goal of this study is to identify the determinants of health among patients with PMD.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-03-23
• Last Update Submitted: 2015-03-23
• Study First Posted: 2015-03-27
• Last Update Posted: 2015-03-27
• Primary Completion: 2018-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• age > 3 years old,
• patient with health insurance,
• causal brain injury before the age of 3,
• Intellectual Quotient < 40 or not assessable,
• motor disability: paraparesis, tetraparesis, hemiparesis, ataxia, neuromuscular disorders, or extrapyramidal motor disorders,
• score at the Gross Motor Function Classification System > 3,
• score at the Functional Independence Measure < 55.

Exclusion Criteria

Subject declaring benefit "psychotropic treatment which" significantly alter the reasoning, discernment or judgment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients With Profound and Multiple Disabilities	quality of life questionnaires	-

Primary Outcome Measures

Name	Time	Method
Caregivers quality of life	36 months	Assessment of quality of life from questionnaires,WHOQOL-Bref, Brief-COPE; - Brief-COPE

Secondary Outcome Measures

Name	Time	Method
emotional distress and subjective burden of natural caregivers,	36 months	Assessment of quality of life from questionnaires,WHOQOL-Bref; * Brief-COPE; * CRA
burnout of institutional caregivers	36 months	Assessment of quality of life from questionnaires,WHOQOL-Bref; * Brief-COPE; * MBI

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France