PRACOH Prevention Breakdown Support Advice Guidance Disability

NCT07496996 | Not Yet Recruiting

• 1 other identifier: 2024-A00862-45
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Person With a Disability; Caregiver

Outcome Measures

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.

  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.

  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.

  one month after the stay

• Assess changes in the patient's anxiety and depression levels following their stay in the dedicated transitional care unit.

  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.

  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.

  at the inclusion and one month after the stay

Study Arms (1)

INTERVENTIONAL

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.

Interventions

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.

INTERVENTIONAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pôle Saint Hélier: lead

Study Sites (1)

Fondation Saint-Hélier

Rennes, 35043, France

Location

Central Study Contacts

Sandrine ROBINEAU, MD

CONTACT

+33299295099; sandrine.robineau@fondationsainthelier.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a single group, but patient carers may be asked to participate in order to assess the impact of staying in a dedicated unit.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-03

Locations

FR (1)