Anticipated Patient and Caregiver Burden: Impact in People with Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Impact of the patient's sense of being a burden on the patient's suicidal ideation
研究概览
简要总结
Amyotrophic lateral sclerosis (ALS) is a degenerative neurological disease that causes progressive motor disability and is life threatening within a few years. The severity of the disease, the progressive loss of autonomy that leads to dependence on family and caregivers, and the lack of effective treatment sometimes leads patients to a loss of hope and to dark thoughts. The prevalence of suicidal ideation is high, with more than one third of people with ALS experiencing it. The psychological suffering of patients is often associated with that of their caregivers. The evaluation of the patients' feeling of being a burden has rarely been addressed in previous studies in ALS on the notion of burden. In this work, the investigators wish to evaluate the patient's ideas of death by also taking into account the caregiver's burden and the patient's feeling of being a burden. They wish to better understand this difficult experience by refocusing the study on the patient himself, which has rarely been addressed in studies on ALS and the notion of burden. By working on the caregiver's burden, both from the caregiver's point of view and as perceived by the patient, the investigators hope to find avenues of intervention and define actions that could help patients and their families and improve the quality of life of the patient-caregiver couple.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •(patient) :
- •Patient is at least 18 years of age.
- •Patient having given informed consent
- •Patient with ALS who has already had at least two multidisciplinary assessments in the ALS center in Marseille with an evaluation by the clinical psychologist.
- •Patient with a motor handicap of grade 3 to 5 on the Rankin score
- •Patient with a primary family caregiver at home (spouse, child) willing to participate in the study
- •Patient who is a beneficiary of or affiliated with a social security plan
- •Inclusion Criteria (caregiver) :
- •Adult subject at least 18 years of age.
- •Subject who has given informed consent.
- •Primary family caregiver of a patient with ALS who agrees to participate in the study
- •Caregiver present during hospital visits.
排除标准
- •Patients with a serious and unstable associated disease, cardiac, oncological, hepatic or renal, psychiatric (schizophrenia, bipolar)
- •Autonomous patient, who does not need the help of a third party for the basic gestures of daily life (Rankin 0 to 2)
- •Patient living in an institution or alone at home
- •Patient with cognitive impairment that interferes with activities of daily living
- •Patients with marked emotional lability (spasmodic crying) due to ALS
- •Patients who have had a recent diagnosis of their disease (less than 6 months)
- •Patients who are unaware of the severity of their condition
- •Any condition that in the opinion of the investigator or psychologist would not be compatible with the study.
- •Exclusion Criteria (caregiver):
- •Subjects with severe and unstable cardiac, oncological, hepatic, renal or other illnesses.
- •Subject with a history of psychiatric illness
研究组 & 干预措施
Psychological assessments
干预措施: Psychological assessments (Behavioral)
结局指标
主要结局
Impact of the patient's sense of being a burden on the patient's suicidal ideation
时间窗: Inclusion visit (month 0)
Columbia scale (highest score meaning better outcome)
次要结局
- Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation(Inclusion visit (month 0))
- Relationship between the patient's feeling of being a burden and the motor disability(Inclusion visit (month 0))
- Relationship between the depression of patient and the caregiver(Inclusion visit (month 0))
- Impact of the caregiver's feeling of hardship on the patient's reasons for living(Inclusion visit (month 0))
- Relationship between the caregiver's perceived distress and the patient's suicidal ideation(Inclusion visit (month 0))
- Relationship between the patient's feeling of being a burden living(Inclusion visit (month 0))
- Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship(Inclusion visit (month 0))
- Impact of the patient's sense of burden and the caregiver's sense of hardship on the quality of life of the patient and the caregiver(Inclusion visit (month 0))
- Relationship between the patient's reasons for living(Inclusion visit (month 0))
- Relationship between caregiver's perceived distress and the patient's cognitive assessment(Inclusion visit (month 0))