PolyhandicapEVAL-POLYNENCT06811441
Third Wave of the EVAL-PLH (POLYhandicap) Cohort: New Eyes
An observational study of Polyhandicap, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyhandicap
- How many people
- 1,102 participants
- Where
- 6 sitesFrance
- Study dates
- 13 Oct 2025to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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;
Show all 17Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Hôpital Marin de Hendaye
Hendaye
Nicolas WOLFF
- Recruiting
Hôpital San Salvadour
Hyères
Marie-Christine ROUSSEAU, marie-christine.rousseau@aphp.fr
- Recruiting
Fondation John Bost
La Force
Sandrine THINNES
- Not yet recruiting
Assistance Publique Des Hopitaux de Marseille
Marseille
Karine BAUMSTARCK, 0491324459, karine.baumstarck@univamu.fr
- Recruiting
CESAP
Paris
Anne-Emmanuelle PIQUET MASSIN
- Recruiting
Hôpital La Roche Guyon
Paris
Thierry BILLETTE DE VILLEMEUR, thierry.billette@aphp.fr
About this study
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.
Read the 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).
- Conditions
- Polyhandicap
What is being measured
The primary outcome is the main question the study is designed to answer.
Health status of patients with PIMD/Polyhandicap
Evaluate the health status of patients with PIMD/Polyhandicap using a standardized questionnaire completed by a physician.
Measured: 2 hours to complete the questionnaire
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start13 Oct 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyhandicapStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- karine Baumstarck, Principal investigator, Assistance Publique des Hôpitaux de Marseille (AP-HM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811441
- Sponsor's protocol ID
- RCAPHM23_0252
- Acronym
- EVAL-POLYNE
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Wave of the EVAL-PLH (POLYhandicap) Cohort: New Eyes
- ClinicalTrials.gov ID
- NCT06811441
- Acronym / sponsor ID
- EVAL-POLYNE / RCAPHM23_0252
- Conditions
- Polyhandicap
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,102 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health status of patients with PIMD/Polyhandicap
Time frame: 2 hours to complete the questionnaire
Evaluate the health status of patients with PIMD/Polyhandicap using a standardized questionnaire completed by a physician.
4 secondary outcomes
Quality of life of patients with PIMD/Polyhandicap
Time frame: 10 minutes to complete the questionnaire
Health status and quality of life of family caregivers
Time frame: 1 hour to complete the self-reported questionnaire
Health status and quality of life of institutional caregivers
Time frame: 30 minutes to complete the self-reported questionnaire
Evolution of the health status of patients, clinical practices and management strategies
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 questionnair
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Polyhandicap
Not yet recruiting
Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities
Respiratory Decompensation, Multiple Disabilities
Recruiting
Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
Polyhandicap
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
karine Baumstarck principal investigator
Assistance Publique des Hôpitaux de Marseille (AP-HM)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyhandicap, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact karine Baumstarck (04 91 32 44 59, karine.baumstarck@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health status of patients with PIMD/Polyhandicap (time frame: 2 hours to complete the questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.