PolyhandicapPolyAgeNCT06222112
Experience Life, Needs and Expectations of Families of Older Polyhandiccaped Persons
An observational study of Polyhandicap, run by Assistance Publique Hopitaux De Marseille at 7 sites in France.
Trial summary
The general objective of PolyAGE is to explore the life experience of familial caregivers of aging persons with polyhandicap (>= 35 years). The investigators will question parents (objective 1) and siblings (objective 2) about the experiences, the social representations, the needs and the expectations, as well as the… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyhandicap
- How many people
- 35 participants
- Where
- 7 sitesFrance
- Study dates
- 24 Sep 2024to 6 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons with severe polyhandicap aged 35 and over. Severe polyhandicap was 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
- Mother or father (>=18 years) of a with severe polyhandicap aged 35 and over at the time of inclusion
- Person (>=18 years) having at least one parent in common with a person with a severe polyhandicap aged 35 and over at the time of inclusion
- Person agreeing to participate after having been informed of the study's objectives and procedures
Who cannot join
- Parents and siblings whose inclusion criteria concerning the Persons with severe polyhandicap are not fulfilled
- Parents and siblings who refuse to participate
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
APHP Hôpital Marin de Hendaye
Hendaye
AP-HP Hôpitaux San Salvadour
Hyères
Fondation John Bost
La Force
Assistance Publique Des Hopitaux de Marseille
Marseille, 13354
Université Aix Marseille
Marseille
Université de Montpellier
Montpellier
Groupe Polyhandicap France (GPF)
Paris
About this study
The general objective of PolyAGE is to explore the life experience of familial caregivers of aging persons with polyhandicap (>= 35 years). The investigators will question parents (objective 1) and siblings (objective 2) about the experiences, the social representations, the needs and the expectations, as well as the mechanisms associated with their choices about their children with polyhandicap. The objective 3 is to co-analyze parents' and siblings' experiences regarding the aging of their relatives with polyhandicap.
Read the detailed description
Context Polyhandicap as a chronic complex disability condition, lead to a combination of profound intellectual disability and serious motor deficit, resulting in the extreme restriction of autonomy and communication. Due to the improvement of preventive actions and supportive care, the life expectancy of these persons is increased In order to assess the issues associated with the aging of people with polyhandicap (an emerging and underexplored phenomenon), life experiences, social representations, specific needs and expectations of familial caregivers (parents and siblings) need to be explored. It is essential to better understand these phenomenon in order to better support and assist these families. The PolyAGE project relies on an interdisciplinary approach, based on social and human sciences (social psychology of health) and public health. PolyAGE is based on a solid network including engaged and volunteer actors.
Objectives The general objective of PolyAGE is to explore the life experience of familial caregivers of aging persons with polyhandicap (>= 35 years). The investigators will question parents (objective 1) and siblings (objective 2) about the experiences, the social representations, the needs and the expectations, as well as the mechanisms associated with their choices about their children with polyhandicap. The objective 3 is to co-analyze parents' and siblings' experiences regarding the aging of their relatives with polyhandicap.
Methods
PolyAGE relies on the EVAL-PLH cohort, initiated in 2015, including persons with polyhandicap, familial and institutional caregivers. Eight teams are involved in PolyAGE: 2 specialized reeducation centers (Hendaye et San Salvadour), the J. Bost Foundation, the Groupe Polyhandicap France (family association), 3 university teams (CeReSS and LPS of Aix Marseille university and SantESiH of Montpellier university), 1 epidemiology team (AP-HM).The investigators propose a pluri-methodological mixt approach combining quantitative and qualitative approaches in a socio-contextual and comprehensive perspective:
- Quantitative approach:
- Evaluations using standardized self-reported questionnaires: quality of life, coping, emotional intelligence, burden.
- Parents: data already available (EVAL-PLH cohort: 2 evaluation times 20151-6 and 2020-21).
- Siblings: data to be collected (phone, mail).
- Qualitative approach:
- Evaluations based on interviews (parents and siblings; 1 confounding factor: participant's sex);
- Combination of interviews content and interpretative phenomenological analysis.
- Methodological triangulation:
- Crossing and confrontation of quantitative and qualitative findings. Perspectives
- Improvement of knowledge and identification of the specific needs/expectations of family caregivers of aging persons with polyhandicap.
- Understanding the underlying reasons behind the choices made by families in terms of support for aging persons with polyhandicap in order to support the transitions related to the joint aging of persons with polyhandicap and their relatives.
- Better supporting families in the aging transition (health professionals, health-decision makers).
- Conditions
- Polyhandicap
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences of parents of aging persons with polyhandicap
Evaluations using standardized self-reported questionnaire: quality of life and evaluation based on interviews to be conducted during the present study
Measured: 30 minutes to fill in the booklet and about 60 minutes for the interview
Secondary outcomes (2)
Experiences of siblings of aging persons with polyhandicap
Evaluations using standardized self-reported questionnaire: quality of life and evaluations based on interviews to be conducted during the present study
Measured: 30 minutes to fill in the booklet and about 60 minutes for the interview
Crossing and confrontation of quantitative and qualitative findings
A cross of quantitative evaluation (questionnaire) and qualitative evaluation (interviews) by methodological triangulation analysis
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start24 Sep 2024
- Primary completion6 May 2026
- Study completion6 May 2026
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- karine baumstarck, PI, Principal investigator, Assistance Publique des Hôpitaux de Marseille (AP-HM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222112
- Sponsor's protocol ID
- RCAPHM23_0212
- Acronym
- PolyAge
- Status last verified
- Oct 2026
- First submitted
- 3 Jan 2024
- Last updated
- 8 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience Life, Needs and Expectations of Families of Older Polyhandiccaped Persons
- ClinicalTrials.gov ID
- NCT06222112
- Acronym / sponsor ID
- PolyAge / RCAPHM23_0212
- Conditions
- Polyhandicap
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 24 Jan 2024 (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 PolyAGE is to explore the life experience of familial caregivers of aging persons with polyhandicap (>= 35 years). The investigators will question parents (objective 1) and siblings (objective 2) about the experiences, the social representations, the needs and the expectations, as well as the mechanisms associated with their choices about their children with polyhandicap. The objective 3 is to co-analyze parents' and siblings' experiences regarding the aging of their relatives with polyhandicap.
Detailed description
Context Polyhandicap as a chronic complex disability condition, lead to a combination of profound intellectual disability and serious motor deficit, resulting in the extreme restriction of autonomy and communication. Due to the improvement of preventive actions and supportive care, the life expectancy of these persons is increased In order to assess the issues associated with the aging of people with polyhandicap (an emerging and underexplored phenomenon), life experiences, social representations, specific needs and expectations of familial caregivers (parents and siblings) need to be explored. It is essential to better understand these phenomenon in order to better support and assist these families. The PolyAGE project relies on an interdisciplinary approach, based on social and human sciences (social psychology of health) and public health. PolyAGE is based on a solid network including engaged and volunteer actors.
Objectives The general objective of PolyAGE is to explore the life experience of familial caregivers of aging persons with polyhandicap (>= 35 years). The investigators will question parents (objective 1) and siblings (objective 2) about the experiences, the social representations, the needs and the expectations, as well as the mechanisms associated with their choices about their children with polyhandicap. The objective 3 is to co-analyze parents' and siblings' experiences regarding the aging of their relatives with polyhandicap.
Methods
PolyAGE relies on the EVAL-PLH cohort, initiated in 2015, including persons with polyhandicap, familial and institutional caregivers. Eight teams are involved in PolyAGE: 2 specialized reeducation centers (Hendaye et San Salvadour), the J. Bost Foundation, the Groupe Polyhandicap France (family association), 3 university teams (CeReSS and LPS of Aix Marseille university and SantESiH of Montpellier university), 1 epidemiology team (AP-HM).The investigators propose a pluri-methodological mixt approach combining quantitative and qualitative approaches in a socio-contextual and comprehensive perspective:
- Quantitative approach:
- Evaluations using standardized self-reported questionnaires: quality of life, coping, emotional intelligence, burden.
- Parents: data already available (EVAL-PLH cohort: 2 evaluation times 20151-6 and 2020-21).
- Siblings: data to be collected (phone, mail).
- Qualitative approach:
- Evaluations based on interviews (parents and siblings; 1 confounding factor: participant's sex);
- Combination of interviews content and interpretative phenomenological analysis.
- Methodological triangulation:
- Crossing and confrontation of quantitative and qualitative findings. Perspectives
- Improvement of knowledge and identification of the specific needs/expectations of family caregivers of aging persons with polyhandicap.
- Understanding the underlying reasons behind the choices made by families in terms of support for aging persons with polyhandicap in order to support the transitions related to the joint aging of persons with polyhandicap and their relatives.
- Better supporting families in the aging transition (health professionals, health-decision makers).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with severe polyhandicap aged 35 and over. Severe polyhandicap was 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 (3 listed)
- Mother or father (>=18 years) of a with severe polyhandicap aged 35 and over at the time of inclusion
- Person (>=18 years) having at least one parent in common with a person with a severe polyhandicap aged 35 and over at the time of inclusion
- Person agreeing to participate after having been informed of the study's objectives and procedures
Key exclusion criteria (2 listed)
- Parents and siblings whose inclusion criteria concerning the Persons with severe polyhandicap are not fulfilled
- Parents and siblings who refuse to participate
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
Experiences of parents of aging persons with polyhandicap
Time frame: 30 minutes to fill in the booklet and about 60 minutes for the interview
Evaluations using standardized self-reported questionnaire: quality of life and evaluation based on interviews to be conducted during the present study
2 secondary outcomes
Experiences of siblings of aging persons with polyhandicap
Time frame: 30 minutes to fill in the booklet and about 60 minutes for the interview
Crossing and confrontation of quantitative and qualitative findings
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
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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. This study is not recruiting at the moment.
karine baumstarck, PI principal investigator
Assistance Publique des Hôpitaux de Marseille (AP-HM)
7 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 7 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 8 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 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences of parents of aging persons with polyhandicap (time frame: 30 minutes to fill in the booklet and about 60 minutes for the interview). 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 8 Oct 2026.