Clinical trial NCT02400528: Prospective Cohort Follow-up of French Patients With Profound and Multiple Disabilities: Healthcare Pathways and Quality of Life Among Patients and Their Families
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paraparesis
Tetraparesis
Hemiparesis
Ataxia
Neuromuscular Disorders
Extrapyramidal Motor Disorders
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Caregivers quality of life
timeFrame: 36 months
Secondary outcomes:
measure: emotional distress and subjective burden of natural caregivers,
timeFrame: 36 months
measure: burnout of institutional caregivers
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.