NCT05632757Recruiting

Anticipated Patient and Caregiver Burden

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

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 126 (estimated)
First submitted: 16 Nov 2022
Start date: 22 Jun 2023
Primary completion date: 22 Dec 2026
Lead sponsor: Assistance Publique Hopitaux De Marseille
Diseases: ALS (motor neurone disease)
NCT number: NCT05632757

What you commit to

Study type: Interventional
Planned participants: 126
From 22 Jun 2023 to the primary completion date, 22 Dec 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Patients with a serious and unstable associated disease, cardiac, oncological, hepatic or renal, psychiatric (schizophrenia, bipolar)
Patient with cognitive impairment that interferes with activities of daily living
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.
Subjects with severe and unstable cardiac, oncological, hepatic, renal or other illnesses.
Subject with a history of psychiatric illness

Other

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
Patients with marked emotional lability (spasmodic crying) due to ALS

Who the study is looking for

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
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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Service Maladies neuromusculaires et SLA Coordinator of this site? Confirm its status	Marseille	France	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.