Third Wave of the EVAL-PLH (POLYhandicap) Cohort: New Eyes
ConditionPolyhandicap
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorAssistance Publique Hopitaux De Marseille
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
Patient with PIMD/Polyhandicap
Patient not meeting all inclusion criteria;
Patient in exclusion period of another research protocol at the time of inclusion.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
2 hours to complete the questionnaireSecondary outcomes
1
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
Time frame
10 minutes to complete the questionnaire2
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
Time frame
1 hour to complete the self-reported questionnaire3
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
Time frame
30 minutes to complete the self-reported questionnaire4
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
Time frame
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 questionnairSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov