New Eyes: Expanding the EVAL-PLH Polyhandicap Cohort

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project aims to broaden enrollment in the EVAL-PLH cohort to reduce geographic and private-structure biases. It follows people with PIMD/Polyhandicap over time to describe health changes, care practices, and family/caregiver experiences. The study design emphasizes longitudinal observation rather than interventional treatments, to identify patterns and determinants in real-world care. Data from participants and their caregivers inform decision-makers and healthcare providers about targeted actions to improve outcomes. Inclusion includes patients aged 3 years and older with PIMD/Polyhandicap and their family or institutional caregivers who understand French and consent where required.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Marin de Hendaye
  Hendaye, France Recruiting
• Hôpital San Salvadour
  Hyères, France Recruiting
• Fondation John Bost
  La Force, France Recruiting
• Cesap
  Paris, France Recruiting
• Hôpital La Roche Guyon
  Paris, France Recruiting
• Assistance Publique Des Hopitaux de Marseille
  Marseille, France Not yet recruiting

Study contacts

• Principal investigator: karine Baumstarck — Assistance Publique des Hôpitaux de Marseille (AP-HM)
• Study coordinator: karine Baumstarck
• Email: karine.baumstarck@univ-amu.fr
• Phone: 04 91 32 44 59

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.