PRACOH Prevention Breakdown Support Advice Guidance Disability

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• 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. [Срок оценки: inclusion * 1 month after the stay]

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: one month after the stay]
• Assess changes in the patient's anxiety and depression levels following their stay in the dedicated transitional care unit. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: within 4 weeks after the 1-month checkup]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• Fondation Saint-Hélier — Rennes

Идентификаторы

NCT: NCT07496996 · 2024-A00862-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗