Идёт набор NCT05632757

Anticipated Patient and Caregiver Burden

Без фазы С лечением Amyotrophic Lateral Sclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Psychological assessments.
Кому может быть актуально: Состояния в реестре: Amyotrophic Lateral Sclerosis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Anticipated Patient and Caregiver Burden: Impact in People with Amyotrophic Lateral Sclerosis

Обзор

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.

Вмешательства

Поведенческое Psychological assessments
The visit will take place during a multidisciplinary assessment in the ALS Center at the Timone Hospital, Neuromuscular Disease and ALS Department. The patient will be accompanied by his/her caregiver. During this multidisciplinary assessment, the patient is present at the hospital between 8am and 4pm. The various scales and self-questionnaires can be completed during this time. The time required to complete these scales and self-questionnaires is estimated to be about 90 minutes.

Первичные конечные точки

Impact of the patient's sense of being a burden on the patient's suicidal ideation [Срок оценки: Inclusion visit (month 0)]

Вторичные конечные точки (12)

Relationship between the patient's feeling of being a burden living [Срок оценки: Inclusion visit (month 0)]
Relationship between the patient's reasons for living [Срок оценки: Inclusion visit (month 0)]
Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship [Срок оценки: 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 [Срок оценки: Inclusion visit (month 0)]
Relationship between the patient's feeling of being a burden and the motor disability [Срок оценки: Inclusion visit (month 0)]
Relationship between the patient's feeling of being a burden and the motor disability [Срок оценки: Inclusion visit (month 0)]
Relationship between the patient's feeling of being a burden and the motor disability [Срок оценки: Inclusion visit (month 0)]
Relationship between the depression of patient and the caregiver [Срок оценки: Inclusion visit (month 0)]
Relationship between the depression of patient and the caregiver [Срок оценки: Inclusion visit (month 0)]
Relationship between the depression of patient and the caregiver [Срок оценки: Inclusion visit (month 0)]
Impact of the caregiver's feeling of hardship on the patient's reasons for living [Срок оценки: Inclusion visit (month 0)]
Impact of the caregiver's feeling of hardship on the patient's reasons for living [Срок оценки: Inclusion visit (month 0)]

Критерии участия

Inclusion Criteria (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.

Exclusion Criteria (patient):

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):