Third Wave of the EVAL-PLH (POLYhandicap) Cohort: New Eyes (EVAL-POLYNE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polyhandicap

Detailed Description

Studies on people with profound intellectual and multiple disabilities (PIMD)/Polyhandicap are rare, involve small numbers and highly heterogeneous groups, and document narrow objectives focused on targeted health problems. Although valuable, these studies provide only fragmentary knowledge of the medical, socio-economic and epidemiological determinants of the health and experience of people with PIMD/Polyhandicap and their families. Existing studies are based on retrospective or cross-sectional data. These study designs do not make it possible to identify causal links between the phenomena observed. Only cohort studies can provide a longitudinal vision, enabling us to study the dynamics of the phenomena observed (care, access to different care structures, environment in the broadest sense, state of health and experiences of these people and their families). The information made available is essential for informing healthcare decision-makers, healthcare professionals and the families of these people, and for proposing the most appropriate targeted actions.

The Eval-PLH cohort of people with PIMD/Polyhandicap was initiated in 2015, with the aim of describing prospective changes in the health characteristics of people with PIMD/Polyhandicap, clinical practices and management strategies for PIMD/Polyhandicap. It also assesses the impact of PIMD/Polyhandicap on the experiences of family carers and the institutional carers (caregivers) who support them.

The 1st wave of observation took place in 2015-2016. Nearly 900 people with PIMD/Polyhandicap, 400 family carers and 400 institutional carers were assessed thanks to the participation of six specialized follow-up care and rehabilitation centers, eight medico-social structures (MAS and IME) and one neuropediatric consultation service. Data mining has enabled us to build up an unprecedented knowledge base. This work confirmed the diversity and evolution of pathologies, the heterogeneity of medical practices and the impact on family and institutional caregivers.

The 2nd wave of observation took place in 2020-2021 and assessed 624 people PIMD/Polyhandicap (132 new cases, 492 cases present in the 1st wave), 226 family carers and 223 institutional carers in four specialized follow-up care and rehabilitation centers and eight medico-social structures. These data are currently being explored and valorized. They provide considerable scientific added value thanks to their longitudinal perspective. A more detailed understanding of the phenomena (through a qualitative approach based on interviews) complements the initial purely quantitative approach.

The present study, which concerns the 3rd evaluation wave, aims to optimize the system, particularly in terms of the representativeness of the populations studied. The extension of the system to less targeted geographical areas and to non-public structures will shed new light on the care organizations and professionals affiliated with these structures, as well as on the experiences of the people cared for (patients and families).

• Study Type: Observational
• Enrollment (Estimated): 1102

Contacts and Locations

• Study Contact: Name: karine Baumstarck; Phone Number: 04 91 32 44 59; Email: karine.baumstarck@univ-amu.fr
• Study Contact Backup: Name: Any Beltran; Phone Number: 04 91 32 45 20; Email: any-alejandra.beltran-anzola@univ-amu.fr

Study Locations

• France
  • Hendaye, France
    • Hôpital Marin de Hendaye
    • Contact: Nicolas WOLFF
  • Hyères, France
    • Hôpital San Salvadour
  • La Force, France
    • Fondation John Bost
    • Contact: Sandrine THINNES
  • Marseille, France
    • Assistance Publique Des Hopitaux de Marseille
    • Contact: Karine BAUMSTARCK; Phone Number: 0491324459; Email: karine.baumstarck@univamu.fr
  • Paris, France
    • CESAP
    • Contact: Anne-Emmanuelle PIQUET MASSIN
  • Paris, France
    • Hôpital La Roche Guyon
    • Contact: Thierry BILLETTE DE VILLEMEUR; Email: thierry.billette@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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;
• 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.

Exclusion Criteria:

• Patient with PIMD/Polyhandicap
• Patient not meeting all inclusion criteria;
• Patient in exclusion period of another research protocol at the time of inclusion.

Family and Institutional caregivers of patient

• Subject not meeting all inclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patients with PIMD/Polyhandicap	Evaluate the quality of life of patients with PIMD/Polyhandicap using a standardized questionnaire completed by institutional caregivers and family caregivers	10 minutes to complete the questionnaire
Health status and quality of life of family caregivers	Evaluate the health status and quality of life of family caregivers using a standardized self-reported questionnaire	1 hour to complete the self-reported questionnaire
Health status and quality of life of institutional caregivers	Evaluate the health status and quality of life of institutional caregivers using a standardized self-reported questionnaire	30 minutes to complete the self-reported questionnaire
Evolution of the health status of patients, clinical practices and management strategies	Identify the determinants of health status and quality of life of patients with PIMD/Polyhandicap, family and institutional caregivers using standardized questionnaires	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: karine Baumstarck, Assistance Publique des Hôpitaux de Marseille (AP-HM)

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RCAPHM23_0252

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No