Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2022-A01748-35 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychological assessments | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological assessments | Behavioral | 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. |
| 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) |
| 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 |
Not provided
Inclusion Criteria (patient) :
Inclusion Criteria (caregiver) :
Exclusion Criteria (patient):
Exclusion Criteria (caregiver):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annie Verschueren | Contact | 0491386578 | 33 | annie.verschueren@ap-hm.fr |
| Annie Verschueren | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Annie Verschueren | AP-HM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Maladies neuromusculaires et SLA | Recruiting | Marseille | 13005 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D003863 | Depression |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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) |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |