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

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.

Study Overview

• Status: Unknown
• Conditions: Ataxia; Hemiparesis; Paraparesis; Neuromuscular Disorders; Tetraparesis; Extrapyramidal Motor Disorders
• Intervention / Treatment: Behavioral: quality of life questionnaires

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Urielle DESALBRES, Director; Phone Number: 04.91.38.27.47; Email: drci@ap-hm.fr
    • Principal Investigator: Pascal AUQUIER, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients With Profound and Multiple Disabilities	Behavioral: quality of life questionnaires

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Publications and helpful links

General Publications

• Hamouda I, Rousseau MC, Beltran Anzola A, Aim MA, de Villemeur TB, Auquier P, Baumstarck K; EVAL-PLH group. The French EVAL-PLH cohort of persons with polyhandicap. Sci Rep. 2022 Jul 22;12(1):12512. doi: 10.1038/s41598-022-16596-3.
• Rousseau MC, Baumstarck K, Valkov M, Felce A, Brisse C, Khaldi-Cherif S, Loundou A, Auquier P, Billette de Villemeur T; French Polyhandicap Group. Impact of severe polyhandicap cared for at home on French informal caregivers' burden: a cross-sectional study. BMJ Open. 2020 Feb 2;10(1):e032257. doi: 10.1136/bmjopen-2019-032257.
• Rousseau MC, Billette de Villemeur T, Khaldi-Cherif S, Brisse C, Felce A, Baumstarck K, Auquier P; French Polyhandicap Group. Adequacy of care management of patients with polyhandicap in the French health system: A study of 782 patients. PLoS One. 2018 Jul 6;13(7):e0199986. doi: 10.1371/journal.pone.0199986. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease; Paresis; Paraparesis; Motor Disorders; Neuromuscular Diseases
• Other Study ID Numbers: 2014-21 (Ethic committee of China-Japan Friendship Hospital); RCAPHM14_0082 (Other Identifier: APHM); 2014-A00953-44 (Other Identifier: IDRCB ANSM)