Person With a DisabilityPRACOHNCT07496996
PRACOH Prevention Breakdown Support Advice Guidance Disability
A study testing the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to their specific needs, has been achieved. in people with Person With a Disability and Caregiver, run by Pôle Saint Hélier at 1 site in France.
Trial summary
The main objective of this prospective interventional study is to evaluate the impact of the stay in the dedicated transitional care unit, through the achievement of the patient's primary objective set at admission, directly related to their specific needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Person With a Disability, Caregiver
- What is being tested?
- the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to their specific needs, has been achieved.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2026to Feb 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- People with disabilities requiring a 4-week stay in a dedicated transitional care unit at POLE MPR ST HELIER
- Men or women, of legal age (over 18)
- Affiliated with a social security scheme or entitled to benefits
- Having given their free and informed consent
- Caregivers:
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- Primary caregiver from the circle of a person with a disability who has agreed to participate in the study.
- Male or female, of legal age (over 18)
- Affiliated with a social security scheme or entitled to benefits
- Having given their free and informed consent
Who cannot join
- Patients:
- Pregnant women, women in labor, or women who are breastfeeding
- Individuals deprived of their liberty by judicial (excluding guardianship or curatorship) or administrative decision
- Individuals undergoing severe psychiatric treatment that may impact the conduct of the protocol, at the investigator's discretion
- Individuals in an emergency situation who are unable to give their prior consent.
- Caregivers:
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- Professional caregivers of participants with disabilities who have agreed to participate in the study.
- Pregnant women, women in labor, or women who are breastfeeding,
- Individuals deprived of their liberty by a judicial (excluding guardianship or curatorship) or administrative decision.
- Individuals undergoing severe psychiatric treatment that may impact the conduct of the protocol, at the investigator's discretion
- Individuals in an emergency situation who are unable to give their prior consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation Saint-Hélier
Rennes, 35043
Sandrine ROBINEAU, DR, +33299295099, sandrine.robineau@fondationsainthelier.com
About this study
Official title: Single-center Prospective Interventional Study Evaluating a Device for Preventing Breakdown Situations in People With Disabilities and Their Primary Caregivers
The main objective of this prospective interventional study is to evaluate the impact of the stay in the dedicated transitional care unit, through the achievement of the patient's primary objective set at admission, directly related to their specific needs.
It is expected to improve knowledge regarding the prevention of situations of breakdown and exhaustion in the living environment of people with disabilities.
- This would improve the life and care pathways as well as the support provided to these individuals and their families and friends.
- It would limit the use of unscheduled care services in crisis situations, thereby improving the quality of care and life.
- Conditions
- Person With a Disability, Caregiver
- Being tested
- the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to their specific needs, has been achieved.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to their specific needs, has been achieved.Other
assess the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to heir specific needs, has been achieved.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTIONAL | Other | INTERVENTIONAL Receives: Other: the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to their specific needs, has been achieved. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of this prospective interventional study is to evaluate the impact of the stay in the dedicated transitional care unit, through the achievement of the patient's main objective set at admission, directly related to their specific needs.
The primary endpoint is the level of achievement of the patient's primary objective, defined upon admission, after a stay in the dedicated transitional care unit. This objective of the stay is defined using a 5-level GAS (Goal Attainment Scale) with 5 levels (from -2 (initial level) to +2 (level achieved beyond the objective)). The GAS is an assessment method focused on the personalisation of care or intervention objectives. It is co-constructed between the patient and the professional and reviewed by an expert trained in the GAS.
Measured: inclusion * 1 month after the stay
Secondary outcomes (11)
Evaluate the impact of the stay in the dedicated transitional care unit by assessing whether the caregiver's primary objective has been achieved, if the caregiver participates in the study.
Level of achievement of the caregiver's primary goal, defined in the week following the patient's admission and assessed one month after the end of the stay using a 5-level GAS scale (as for the patient in the primary endpoint).
Measured: at the inclusion and one month after the stay
Evaluate the main factor explaining the change in the objective perceived by the patient or caregiver and that perceived by the physician.
The data will be examined using a descriptive approach, with the aim of identifying the individual factors identified by the patient (or cargiver) and the physician. If the number of distinct factors allow it, their frequencies will be reported; otherwise, a qualitative descriptive analysis will be conducted. A comparison between the factors identified by the participant and those identified by the physician will also be performed.
Measured: one month after the stay
Assess changes in the patient's anxiety and depression levels following their stay in the dedicated transitional care unit.
Patient anxiety and depression levels as measured by the Hospital Anxiety and Depression Scale (HAD) anxiety score
Interpretation:
The HAD (Hospital Anxiety and Depression) scale is a tool used to screen for anxiety and depressive disorders. Seven questions (odd-numbered items) relate to anxiety, and seven others (even-numbered items) relate to depression, yielding two scores (maximum score for each scale = 21).
The following interpretation can be applied to each score:
- 7 or less: no symptoms.
- 8 to 10: questionable symptoms.
- 11 or more: definite symptoms.
Measured: at the inclusion and one month after the stay
Evaluate changes in the caregiver's anxiety and depression levels following their stay in the dedicated transitional care unit, if the caregiver participates in the study.
Caregiver anxiety and depression levels based on the anxiety score on the Hospital Anxiety and Depression Scale (HAD)
Measured: at the inclusion and one month after the stay
Evaluate changes in the perceived burden following a stay in the dedicated transitional care unit, if the caregiver participates in the study.
Burden perceived by the caregiver as assessed by the Zarit scale
Measured: at the inclusion and one month after the stay
Evaluate changes in the patient's quality of life following their stay in the dedicated transitional care unit.
Patient quality of life assessed using the EQ-5D-5L scale
Measured: at the inclusion and one month after the stay
Evaluate changes in the patient's perceived state of health following their stay in the dedicated transitional care unit.
Health status as perceived by the patient, assessed using the EQ-5D-5L scale
Measured: at the inclusion and one month after
Evaluate changes in the caregiver's quality of life following their stay in the dedicated transitional care unit, if the caregiver participates in the study.
Caregiver quality of life assessed using the EQ-5D-5L scale
Measured: at the inclusion and one month after
Evaluate changes in the caregiver's perceived health status following a stay in the dedicated transitional care unit.
Caregiver-perceived health status assessed using the EQ-5D-5L scale
Measured: at the inclusion and one month after the stay
Evaluate the associations between the characteristics of participants at inclusion and the degree to which the objectives defined by the GAS scale were achieved.
Quantitative associations between participant characteristics and GAS goal achievement scores.
Measured: at the end of the study
Qualitatively explore the feedback from patients and their caregivers (if the caregiver participates in the study) on their stay in the dedicated transitional care unit.
The data will be examined using a qualitative descriptive approach, aiming to identify emerging themes and sub-themes relating to participants' experiences, perceptions, and suggestions.
Measured: within 4 weeks after the 1-month checkup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start29 May 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Person With a DisabilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single group, but patient carers may be asked to participate in order to assess the impact of staying in a dedicated unit.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496996
- Sponsor's protocol ID
- 2024-A00862-45
- Acronym
- PRACOH
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Prospective Interventional Study Evaluating a Device for Preventing Breakdown Situations in People With Disabilities and Their Primary Caregivers
- ClinicalTrials.gov ID
- NCT07496996
- Acronym / sponsor ID
- PRACOH / 2024-A00862-45
- Conditions
- Person With a Disability, Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 27 Mar 2026 (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 main objective of this prospective interventional study is to evaluate the impact of the stay in the dedicated transitional care unit, through the achievement of the patient's primary objective set at admission, directly related to their specific needs.
It is expected to improve knowledge regarding the prevention of situations of breakdown and exhaustion in the living environment of people with disabilities.
- This would improve the life and care pathways as well as the support provided to these individuals and their families and friends.
- It would limit the use of unscheduled care services in crisis situations, thereby improving the quality of care and life.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single group, but patient carers may be asked to participate in order to assess the impact of staying in a dedicated unit.
| Arm | Type | Receives |
|---|---|---|
| INTERVENTIONAL | Other | Other: the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to their specific needs, has been achieved.INTERVENTIONAL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients:
- Caregivers:
Key exclusion criteria (11 listed)
- Patients:
- Caregivers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to their specific needs, has been achieved.assess the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to heir specific needs, has been achieved. | Other | INTERVENTIONAL |
Primary outcome
The main objective of this prospective interventional study is to evaluate the impact of the stay in the dedicated transitional care unit, through the achievement of the patient's main objective set at admission, directly related to their specific needs.
Time frame: inclusion * 1 month after the stay
The primary endpoint is the level of achievement of the patient's primary objective, defined upon admission, after a stay in the dedicated transitional care unit. This objective of the stay is defined using a 5-level GAS (Goal Attainment Scale) with 5 levels (from -2 (initial level) to +2 (level achieved beyond the objective)). The GAS is an assessment method focused on the personalisation of care or intervention objectives. It is co-constructed between the patient and the professional and reviewed by an expert trained in the GAS.
11 secondary outcomes
Evaluate the impact of the stay in the dedicated transitional care unit by assessing whether the caregiver's primary objective has been achieved, if the caregiver participates in the study.
Time frame: at the inclusion and one month after the stay
Evaluate the main factor explaining the change in the objective perceived by the patient or caregiver and that perceived by the physician.
Time frame: one month after the stay
Assess changes in the patient's anxiety and depression levels following their stay in the dedicated transitional care unit.
Time frame: at the inclusion and one month after the stay
Evaluate changes in the caregiver's anxiety and depression levels following their stay in the dedicated transitional care unit, if the caregiver participates in the study.
Time frame: at the inclusion and one month after the stay
Evaluate changes in the perceived burden following a stay in the dedicated transitional care unit, if the caregiver participates in the study.
Time frame: at the inclusion and one month after the stay
Evaluate changes in the patient's quality of life following their stay in the dedicated transitional care unit.
Time frame: at the inclusion and one month after the stay
Evaluate changes in the patient's perceived state of health following their stay in the dedicated transitional care unit.
Time frame: at the inclusion and one month after
Evaluate changes in the caregiver's quality of life following their stay in the dedicated transitional care unit, if the caregiver participates in the study.
Time frame: at the inclusion and one month after
Evaluate changes in the caregiver's perceived health status following a stay in the dedicated transitional care unit.
Time frame: at the inclusion and one month after the stay
Evaluate the associations between the characteristics of participants at inclusion and the degree to which the objectives defined by the GAS scale were achieved.
Time frame: at the end of the study
Qualitatively explore the feedback from patients and their caregivers (if the caregiver participates in the study) on their stay in the dedicated transitional care unit.
Time frame: within 4 weeks after the 1-month checkup
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 15 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the impact of the stay in the dedicated transitional care unit by evaluating whether the patient's primary objective, set at admission and directly related to their specific needs, has been achieved. in people with Person With a Disability and Caregiver, run by Pôle Saint Hélier at 1 site 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 10 inclusion and 11 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Sandrine ROBINEAU, MD (+33299295099, sandrine.robineau@fondationsainthelier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective of this prospective interventional study is to evaluate the impact of the stay in the dedicated transitional care unit, through the achievement of the patient's main objective set at admission, directly related to their specific needs. (time frame: inclusion * 1 month after the stay). 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 15 Sep 2026.