PRACOH Prevention Breakdown Support Advice Guidance Disability (PRACOH)

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.

Study Overview

• Status: Recruiting
• Conditions: Caregiver; Person With a Disability
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandrine ROBINEAU, MD; Phone Number: +33299295099; Email: sandrine.robineau@fondationsainthelier.com

Study Locations

• France
  • Rennes, France, 35043
    • Recruiting
    • Fondation Saint-Hélier
    • Contact: Sandrine ROBINEAU, DR; Phone Number: +33299295099; Email: sandrine.robineau@fondationsainthelier.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	inclusion * 1 month after the stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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)	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	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	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	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	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	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.	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.	within 4 weeks after the 1-month checkup

Collaborators and Investigators

• Sponsor: Pôle Saint Hélier

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A00862-45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No