Anticipated Patient and Caregiver Burden

NCT05632757 | Recruiting

• 2 other identifiers: RCAPHM22_0204ID-RCB
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis; caregiver; burden; depression

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (17)

• Relationship between the patient's feeling of being a burden living

  Inclusion visit (month 0)

• Relationship between the patient's reasons for living

  Inclusion visit (month 0)

• Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship

  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

  Inclusion visit (month 0)

• Relationship between the patient's feeling of being a burden and the motor disability

  Inclusion visit (month 0)

Study Arms (1)

Psychological assessments

EXPERIMENTAL

Behavioral: Psychological assessments

Interventions

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.

Psychological assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects with severe and unstable cardiac, oncological, hepatic, renal or other illnesses.
• Subject with a history of psychiatric illness

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service Maladies neuromusculaires et SLA

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Depression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Annie Verschueren

  AP-HM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie Verschueren

CONTACT

0491386578; annie.verschueren@ap-hm.fr

Annie Verschueren

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 1, 2022
• Study Start: June 22, 2023
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): June 22, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)