Anticipated Patient and Caregiver Burden

Study Overview
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Brief Summary
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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.

Official Title
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Anticipated Patient and Caregiver Burden: Impact in People With Amyotrophic Lateral Sclerosis

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Behavioral: Psychological assessments


Participation Criteria
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Eligibility Criteria
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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): Subjects with severe and unstable cardiac, oncological, hepatic, renal or other illnesses. Subject with a history of psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological assessments<br> | Behavioral: Psychological assessments<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the patient's sense of being a burden on the patient's suicidal ideation | Columbia scale (highest score meaning better outcome) | Inclusion visit (month 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between the patient's feeling of being a burden living | Patient's Feelings of Burden Scale (highest score meaning worst outcome) | Inclusion visit (month 0) | 
| Relationship between the patient's reasons for living | Patient Reasons for Living Scale (highest score meaning worst outcome) | Inclusion visit (month 0) | 
| Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship | Patient's sense of burden scale and Zarit Caregiver Exertion Scale | 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 | WHOQOL-Bref (World Health Organization Quality of Life, highest score meaning better outcome) | Inclusion visit (month 0) | 
| Relationship between the patient's feeling of being a burden and the motor disability | Beck scale (highest score meaning worse outcome) | Inclusion visit (month 0) | 
| Relationship between the patient's feeling of being a burden and the motor disability | Rankin scale (highest score meaning worse outcome) | Inclusion visit (month 0) | 
| Relationship between the patient's feeling of being a burden and the motor disability | ALSFRS score (highest score meaning better outcome) | Inclusion visit (month 0) | 
| Relationship between the depression of patient and the caregiver | Beck scale (highest score meaning worse outcome) | Inclusion visit (month 0) | 
| Relationship between the depression of patient and the caregiver | Rankin scale (highest score meaning worse outcome) | Inclusion visit (month 0) | 
| Relationship between the depression of patient and the caregiver | ALSFRS score (highest score meaning better outcome) | Inclusion visit (month 0) | 
| Impact of the caregiver's feeling of hardship on the patient's reasons for living | Patient Reasons for Living Scale (highest score meaning worst outcome) | Inclusion visit (month 0) | 
| Impact of the caregiver's feeling of hardship on the patient's reasons for living | Columbia Scale (highest score meaning better outcome) | Inclusion visit (month 0) | 
| Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation | Patient Reasons for Living Scale (highest score meaning worst outcome) | Inclusion visit (month 0) | 
| Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation | Columbia Scale (highest score meaning better outcome) | Inclusion visit (month 0) | 
| Relationship between the caregiver's perceived distress and the patient's suicidal ideation | Zarit scale (highest score meaning worse outcome) | Inclusion visit (month 0) | 
| Relationship between the caregiver's perceived distress and the patient's suicidal ideation | Columbia Scale (highest score meaning better outcome) | Inclusion visit (month 0) | 
| Relationship between caregiver's perceived distress and the patient's cognitive assessment | ECAS score (Cognitif Edinburgh Cognitive and Behavioural ALS Screen) (highest score meaning better outcome) | Inclusion visit (month 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amyotrophic lateral sclerosis, caregiver, burden, depression