Service Maladies neuromusculaires et SLA
Marseille, 13005, France
Location status: Recruiting
NCT Number: NCT05632757
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Marseille, 13005, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(patient) :
Inclusion criteria
(caregiver) :
Exclusion criteria
(patient):
Exclusion criteria
(caregiver):
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.
Time frame: Inclusion visit (month 0)
Columbia scale (highest score meaning better outcome)
Time frame: Inclusion visit (month 0)
Patient's Feelings of Burden Scale (highest score meaning worst outcome)
Time frame: Inclusion visit (month 0)
Patient Reasons for Living Scale (highest score meaning worst outcome)
Time frame: Inclusion visit (month 0)
Patient's sense of burden scale and Zarit Caregiver Exertion Scale
Time frame: Inclusion visit (month 0)
WHOQOL-Bref (World Health Organization Quality of Life, highest score meaning better outcome)
Time frame: Inclusion visit (month 0)
Beck scale (highest score meaning worse outcome)
Time frame: Inclusion visit (month 0)
Rankin scale (highest score meaning worse outcome)
Time frame: Inclusion visit (month 0)
ALSFRS score (highest score meaning better outcome)
Time frame: Inclusion visit (month 0)
Beck scale (highest score meaning worse outcome)
Time frame: Inclusion visit (month 0)
Rankin scale (highest score meaning worse outcome)
Time frame: Inclusion visit (month 0)
ALSFRS score (highest score meaning better outcome)
Time frame: Inclusion visit (month 0)
Patient Reasons for Living Scale (highest score meaning worst outcome)
Time frame: Inclusion visit (month 0)
Columbia Scale (highest score meaning better outcome)
Time frame: Inclusion visit (month 0)
Patient Reasons for Living Scale (highest score meaning worst outcome)
Time frame: Inclusion visit (month 0)
Columbia Scale (highest score meaning better outcome)
Time frame: Inclusion visit (month 0)
Zarit scale (highest score meaning worse outcome)
Time frame: Inclusion visit (month 0)
Columbia Scale (highest score meaning better outcome)
Time frame: Inclusion visit (month 0)
ECAS score (Cognitif Edinburgh Cognitive and Behavioural ALS Screen) (highest score meaning better outcome)
Contact information is provided by the study sponsor or research team.
Assistance Publique Hopitaux De Marseille
Other
Anticipated Patient and Caregiver Burden: Impact in People with Amyotrophic Lateral Sclerosis
Acronym: FARP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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