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

Hemiparesis Clinical Trial

— Eval-PLH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02400528
• Other study ID #: 2014-21
• Secondary ID: RCAPHM14_0082201
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2015
• Last updated: March 23, 2015
• Start date: February 2015
• Est. completion date: February 2019

Study information

• Verified date: February 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ataxia
• Disease
• Extrapyramidal Motor Disorders
• Hemiparesis
• Neuromuscular Diseases
• Neuromuscular Disorders
• Paraparesis
• Tetraparesis

Intervention

Behavioral:
• quality of life questionnaires

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux 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	Caregivers quality of life	Assessment of quality of life from questionnaires,WHOQOL-Bref, Brief-COPE; - Brief-COPE	36 months	No
Secondary	emotional distress and subjective burden of natural caregivers,	Assessment of quality of life from questionnaires,WHOQOL-Bref; Brief-COPE; CRA	36 months	No
Secondary	burnout of institutional caregivers	Assessment of quality of life from questionnaires,WHOQOL-Bref; Brief-COPE; MBI	36 months	No