Single-center Prospective Interventional Study Evaluating a Device for Preventing Breakdown Situations in People With Disabilities and Their Primary Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
INTERVENTIONAL
INTERVENTIONAL
干预措施: 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)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
- 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 stay)
- 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 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.(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.(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.(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.(within 4 weeks after the 1-month checkup)