Clinical trial NCT05632757: Anticipated Patient and Caregiver Burden
Official title: Anticipated Patient and Caregiver Burden: Impact in People with Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis
caregiver
burden
depression
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Impact of the patient's sense of being a burden on the patient's suicidal ideation
timeFrame: Inclusion visit (month 0)
Secondary outcomes:
measure: Relationship between the patient's feeling of being a burden living
timeFrame: Inclusion visit (month 0)
measure: Relationship between the patient's reasons for living
timeFrame: Inclusion visit (month 0)
measure: Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship
timeFrame: Inclusion visit (month 0)
measure: 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
timeFrame: Inclusion visit (month 0)
measure: Relationship between the patient's feeling of being a burden and the motor disability
timeFrame: Inclusion visit (month 0)
measure: Relationship between the patient's feeling of being a burden and the motor disability
timeFrame: Inclusion visit (month 0)
measure: Relationship between the patient's feeling of being a burden and the motor disability
timeFrame: Inclusion visit (month 0)
measure: Relationship between the depression of patient and the caregiver
timeFrame: Inclusion visit (month 0)
measure: Relationship between the depression of patient and the caregiver
timeFrame: Inclusion visit (month 0)
measure: Relationship between the depression of patient and the caregiver
timeFrame: Inclusion visit (month 0)
measure: Impact of the caregiver's feeling of hardship on the patient's reasons for living
timeFrame: Inclusion visit (month 0)
measure: Impact of the caregiver's feeling of hardship on the patient's reasons for living
timeFrame: Inclusion visit (month 0)
measure: Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
timeFrame: Inclusion visit (month 0)
measure: Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
timeFrame: Inclusion visit (month 0)
measure: Relationship between the caregiver's perceived distress and the patient's suicidal ideation
timeFrame: Inclusion visit (month 0)
measure: Relationship between the caregiver's perceived distress and the patient's suicidal ideation
timeFrame: Inclusion visit (month 0)
measure: Relationship between caregiver's perceived distress and the patient's cognitive assessment
timeFrame: Inclusion visit (month 0)
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service Maladies neuromusculaires et SLA
Study officials:
affiliation: AP-HM
name: Annie Verschueren
role: PRINCIPAL_INVESTIGATOR
References: