Understanding the burden on ALS patients and their caregivers

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

This study looks at the emotional struggles faced by people with ALS and their caregivers to see how they feel about being a burden and the stress that comes with it.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (other)
• Locations: 1 site (Marseille)
• Trial ID: NCT05632757 on ClinicalTrials.gov

What this trial studies

This study focuses on evaluating the psychological burden experienced by patients with amyotrophic lateral sclerosis (ALS) and their caregivers. It aims to assess the patients' feelings of being a burden and the associated psychological distress, including suicidal ideation. The study involves psychological assessments conducted on patients who have undergone multidisciplinary evaluations at a specialized ALS center in Marseille, along with their primary family caregivers. By centering the research on the patient's perspective, the study seeks to provide insights into the emotional challenges faced by both patients and caregivers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with ALS who have undergone at least two multidisciplinary assessments and have a primary family caregiver willing to participate.

Not a fit: Patients who are autonomous and do not require assistance from caregivers, or those with serious unstable associated diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved psychological support and interventions for ALS patients and their caregivers.

How similar studies have performed: While the focus on caregiver burden in ALS is less explored, similar studies in other chronic conditions have shown the importance of addressing psychological aspects, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Marseille

• Service Maladies neuromusculaires et SLA — Marseille, France (RECRUITING)

Study contacts

• Principal investigator: Annie Verschueren — AP-HM
• Study coordinator: Annie Verschueren

Conditions: Amyotrophic Lateral Sclerosis, amyotrophic lateral sclerosis, caregiver, burden, depression