NCT06811441

Brief Summary

The general objective of the EVAL-PolyNE project is to improve the representativeness of the EVAL-PLH cohort by broadening participation in the John Bost Foundation, due to its geographical particularity and its private valence.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
1,102

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

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 Progress96%
Mar 2025Sep 2026

First Submitted

Initial submission to the registry

January 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

January 30, 2025

Last Update Submit

January 30, 2025

Conditions

Polyhandicap

Outcome Measures

Primary Outcomes (1)

  • Health status of patients with PIMD/Polyhandicap

    Evaluate the health status of patients with PIMD/Polyhandicap using a standardized questionnaire completed by a physician.

    2 hours to complete the questionnaire

Secondary Outcomes (4)

  • Quality of life of patients with PIMD/Polyhandicap

    10 minutes to complete the questionnaire

  • Health status and quality of life of family caregivers

    1 hour to complete the self-reported questionnaire

  • Health status and quality of life of institutional caregivers

    30 minutes to complete the self-reported questionnaire

  • Evolution of the health status of patients, clinical practices and management strategies

    2 hours to complete the patient questionnaire by the physician / 1 hour to complete the family caregiver self-reported questionnaire / 30 minutes to complete the institutional caregiver self-reported questionnair

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with a PIMD/Polyhandicap defined according to the following criteria: * Presence of a brain lesion that occurred before the age of 3, * IQ below 40 or not assessable, * Motor handicap: para/tetraparesis or hemiparesis, * Gross Motor Function Classification System score of III, IV or V, * Functional Independence Measure score below 55

You may qualify if:

  • Patient with PIMD/Polyhandicap
  • Patient for whom the legal representative has received the information note of the EVAL-PLH cohort and has not expressed opposition to the collection of patient data;
  • Patient aged at least 3 years;
  • Patient affiliated to a health insurance scheme;
  • Patient treated within the department of the participating center;
  • Patient for whom the legal representative understands the French language;
  • Patient with a PIMD/Polyhandicap
  • Family caregivers of patient
  • Subject identified by the care structure as the reference family caregiver;
  • Subject aged at least 18 years;
  • Subject who understands the French language and is able to complete self-questionnaires;
  • Subject who has received the information notice and has not expressed opposition to participating in this project
  • Institutinal caregivers of patient
  • Subject identified by the care structure as the reference institutional caregiver of at least one patient included in this project;
  • Subject aged at least 18 years;
  • +2 more criteria

You may not qualify if:

  • Patient with PIMD/Polyhandicap
  • Family and Institutional caregivers of patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital Marin de Hendaye

Hendaye, France

Location

Hôpital San Salvadour

Hyères, France

Location

Fondation John Bost

La Force, France

Location

Assistance Publique Des Hopitaux de Marseille

Marseille, France

Location

CESAP

Paris, France

Location

Hôpital La Roche Guyon

Paris, France

Location

Study Officials

  • karine Baumstarck

    Assistance Publique des Hôpitaux de Marseille (AP-HM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

karine Baumstarck

CONTACT

04 91 32 44 59karine.baumstarck@univ-amu.fr

Any Beltran

CONTACT

04 91 32 45 20any-alejandra.beltran-anzola@univ-amu.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 6, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 6, 2025

Record last verified: 2025-01

Locations

FR(6)