CClinicalTrials.gg
RecruitingNCT07496996PRACOHUpdated Sep 15, 2026

PRACOH Prevention Breakdown Support Advice Guidance Disability

An interventional study of 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 Person With a Disability and Caregiver, sponsored by Pôle Saint Hélier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Pôle Saint Hélier · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Person With a Disability
  • Caregiver
03

In context

Lead sponsor

Pôle Saint Hélier is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    • 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

Exclusion criteria

Exclusion Criteria:

  • 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:

    • 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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    INTERVENTIONAL

    INTERVENTIONAL

    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.

Interventions

  • Otherthe 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: inclusion * 1 month after the stay

Secondary outcomes

  1. 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).

    Time frame: at the inclusion and one month after the stay

  2. 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.

    Time frame: one month after the stay

  3. 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.

    Time frame: at the inclusion and one month after the stay

  4. 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)

    Time frame: at the inclusion and one month after the stay

  5. 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

    Time frame: at the inclusion and one month after the stay

  6. 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

    Time frame: at the inclusion and one month after the stay

  7. 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

    Time frame: at the inclusion and one month after

  8. 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

    Time frame: at the inclusion and one month after

  9. 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

    Time frame: at the inclusion and one month after the stay

  10. 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.

    Time frame: at the end of the study

  11. 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.

    Time frame: within 4 weeks after the 1-month checkup

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07496996
Lead sponsor
Pôle Saint Hélier
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
May 29, 2026
Primary completion
Feb 2029 (estimated)
Completion
Feb 2029 (estimated)
Last update
Sep 15, 2026

Study contacts

Sandrine ROBINEAU, MD
Contact
sandrine.robineau@fondationsainthelier.com
+33299295099

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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