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

Study Overview
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Brief Summary
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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.

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

Conditions
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Paraparesis, Tetraparesis, Hemiparesis, Ataxia, Neuromuscular Disorders, Extrapyramidal Motor Disorders

Intervention / Treatment
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* Behavioral: quality of life questionnaires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients With Profound and Multiple Disabilities<br> | Behavioral: quality of life questionnaires<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregivers quality of life | Assessment of quality of life from questionnaires,WHOQOL-Bref, Brief-COPE - Brief-COPE | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional distress and subjective burden of natural caregivers, | Assessment of quality of life from questionnaires,WHOQOL-Bref Brief-COPE CRA | 36 months | 
| burnout of institutional caregivers | Assessment of quality of life from questionnaires,WHOQOL-Bref Brief-COPE MBI | 36 months |