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NCT Number: NCT07496996

PRACOH Prevention Breakdown Support Advice Guidance Disability

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.

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Key information

Conditions

Person With a Disability Caregiver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.
  • Individuals already admitted to a healthcare or social care facility for purposes other than research.
  • 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.

Treatment and study plan

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.

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.

    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.

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.

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

    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).

  2. 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

    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.

  3. 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

    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.

  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.

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

    Caregiver anxiety and depression levels based on the anxiety score on the Hospital Anxiety and Depression Scale (HAD)

  5. 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

    Burden perceived by the caregiver as assessed by the Zarit scale

  6. 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

    Patient quality of life assessed using the EQ-5D-5L scale

  7. 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

    Health status as perceived by the patient, assessed using the EQ-5D-5L scale

  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.

    Time frame: at the inclusion and one month after

    Caregiver quality of life assessed using the EQ-5D-5L scale

  9. 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

    Caregiver-perceived health status assessed using the EQ-5D-5L scale

  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.

    Time frame: at the end of the study

    Quantitative associations between participant characteristics and GAS goal achievement scores.

  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.

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandrine ROBINEAU, MD

CONTACT

[email protected]

+33299295099

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Registry information

Official study title

Single-center Prospective Interventional Study Evaluating a Device for Preventing Breakdown Situations in People With Disabilities and Their Primary Caregivers

Acronym: PRACOH

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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