NCT02400528

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 27, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

February 4, 2015

Last Update Submit

March 23, 2015

Conditions

ParaparesisTetraparesisHemiparesisAtaxiaNeuromuscular DisordersExtrapyramidal Motor Disorders

Outcome Measures

Primary Outcomes (1)

  • Caregivers quality of life

    Assessment of quality of life from questionnaires,WHOQOL-Bref, Brief-COPE \- Brief-COPE

    36 months

Secondary Outcomes (2)

  • emotional distress and subjective burden of natural caregivers,

    36 months

  • burnout of institutional caregivers

    36 months

Study Arms (1)

Patients With Profound and Multiple Disabilities

OTHER
Behavioral: quality of life questionnaires

Interventions

quality of life questionnairesBEHAVIORAL
Patients With Profound and Multiple Disabilities

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

Related Publications (6)

  • Baumstarck K, Del Duca S, El Ouazzani H, Hamouda I, Beltran Anzola A, Aim MA, Rousseau MC. Increased Life Expectancy of People With Profound Intellectual and Multiple Disabilities: What Does It Change for Parents? J Appl Res Intellect Disabil. 2025 Jan;38(1):e70018. doi: 10.1111/jar.70018.

    PMID: 39934966DERIVED

  • Rousseau MC, Beltran A, Hamouda I, Aim MA, Felce A, Lind K, Khaldi N, El Ouazzani H, Auquier P, de Villemeur TB, Baumstarck K. Impact of caring for patients with polyhandicap on institutional health care workers' quality of life: a cross-sectional and longitudinal evaluation. Front Public Health. 2024 Oct 18;12:1427289. doi: 10.3389/fpubh.2024.1427289. eCollection 2024.

    PMID: 39494083DERIVED

  • Baumstarck K, Hamouda I, Aim MA, Anzola AB, Khaldi-Cherif S, Felce A, Maincent K, Lind K, Auquier P, Billette de Villemeur T, Rousseau MC; and the EVAL-P. L. H. Group. Health care management adequacy among French persons with severe profound intellectual and multiple disabilities: a longitudinal study. BMC Health Serv Res. 2024 Jan 18;24(1):99. doi: 10.1186/s12913-024-10552-9.

    PMID: 38238747DERIVED

  • 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.

    PMID: 35869128DERIVED

  • 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.

    PMID: 32014871DERIVED

  • 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.

    PMID: 29979745DERIVED

MeSH Terms

Conditions

ParaparesisQuadriplegiaParesisAtaxiaNeuromuscular Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsParalysisDyskinesias

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

March 27, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2019

Last Updated

March 27, 2015

Record last verified: 2015-02

Locations

FR(1)