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PRACOH Prevention Breakdown Support Advice Guidance Disability

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07496996
Acronym
PRACOH
Enrollment
100
Registered
2026-03-27
Start date
2026-05-29
Completion date
2029-02-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver, Person With a Disability

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.

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.

Sponsors

Pôle Saint Hélier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
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.inclusion * 1 month after the stayThe 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

MeasureTime frameDescription
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 stayLevel 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).
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 stayThe 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.
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 stayPatient 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.
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 stayCaregiver anxiety and depression levels based on the anxiety score on the Hospital Anxiety and Depression Scale (HAD)
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 stayBurden perceived by the caregiver as assessed by the Zarit scale
Evaluate changes in the patient's quality of life following their stay in the dedicated transitional care unit.at the inclusion and one month after the stayPatient quality of life assessed using the EQ-5D-5L scale
Evaluate changes in the patient's perceived state of health following their stay in the dedicated transitional care unit.at the inclusion and one month afterHealth status as perceived by the patient, assessed using the EQ-5D-5L scale
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.at the inclusion and one month afterCaregiver quality of life assessed using the EQ-5D-5L scale
Evaluate changes in the caregiver's perceived health status following a stay in the dedicated transitional care unit.at the inclusion and one month after the stayCaregiver-perceived health status assessed using the EQ-5D-5L scale
Evaluate the associations between the characteristics of participants at inclusion and the degree to which the objectives defined by the GAS scale were achieved.at the end of the studyQuantitative associations between participant characteristics and GAS goal achievement scores.
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.within 4 weeks after the 1-month checkupThe data will be examined using a qualitative descriptive approach, aiming to identify emerging themes and sub-themes relating to participants' experiences, perceptions, and suggestions.

Countries

France

Contacts

CONTACTSandrine ROBINEAU, MD
sandrine.robineau@fondationsainthelier.com+33299295099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026