Anticipated Patient and Caregiver Burden
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Behavioral: Psychological assessments
- Registration Number
- NCT05632757
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Psychological assessments Psychological assessments -
- Primary Outcome Measures
Name Time Method Impact of the patient's sense of being a burden on the patient's suicidal ideation Inclusion visit (month 0) Columbia scale (highest score meaning better outcome)
- Secondary Outcome Measures
Name Time Method Relationship between the patient's feeling of being a burden living Inclusion visit (month 0) Patient's Feelings of Burden Scale (highest score meaning worst outcome)
Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship Inclusion visit (month 0) Patient's sense of burden scale and Zarit Caregiver Exertion Scale
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) WHOQOL-Bref (World Health Organization Quality of Life, highest score meaning better outcome)
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation Inclusion visit (month 0) Columbia Scale (highest score meaning better outcome)
Impact of the caregiver's feeling of hardship on the patient's reasons for living Inclusion visit (month 0) Columbia Scale (highest score meaning better outcome)
Relationship between the patient's reasons for living Inclusion visit (month 0) Patient Reasons for Living Scale (highest score meaning worst outcome)
Relationship between the patient's feeling of being a burden and the motor disability Inclusion visit (month 0) ALSFRS score (highest score meaning better outcome)
Relationship between the depression of patient and the caregiver Inclusion visit (month 0) ALSFRS score (highest score meaning better outcome)
Relationship between the caregiver's perceived distress and the patient's suicidal ideation Inclusion visit (month 0) Columbia Scale (highest score meaning better outcome)
Relationship between caregiver's perceived distress and the patient's cognitive assessment Inclusion visit (month 0) ECAS score (Cognitif Edinburgh Cognitive and Behavioural ALS Screen) (highest score meaning better outcome)
Trial Locations
- Locations (1)
Service Maladies neuromusculaires et SLA
🇫🇷Marseille, France