Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05632757

Anticipated Patient and Caregiver Burden

Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-11-25

126

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Anticipated Patient and Caregiver Burden

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is at least 18 years of age
  • Patient has given informed consent
  • Patient with ALS who has had at least two multidisciplinary assessments in the ALS center in Marseille with evaluation by a clinical psychologist
  • Patient has a motor handicap graded 3 to 5 on the Rankin score
  • Patient has a primary family caregiver at home willing to participate
  • Patient is affiliated with a social security plan
  • Caregiver is at least 18 years old
  • Caregiver has given informed consent
  • Caregiver is the primary family caregiver of a patient with ALS and agrees to participate
  • Caregiver is present during hospital visits
Not Eligible

You will not qualify if you...

  • Patient has a serious and unstable associated disease such as cardiac, oncological, hepatic, renal, or psychiatric illness (schizophrenia, bipolar)
  • Patient is autonomous and does not need help with basic daily activities (Rankin 0 to 2)
  • Patient lives in an institution or alone at home
  • Patient has cognitive impairment interfering with daily activities
  • Patient has marked emotional lability (spasmodic crying) due to ALS
  • Patient has had a recent diagnosis (less than 6 months)
  • Patient is unaware of the severity of their condition
  • Any condition judged incompatible with the study by the investigator or psychologist
  • Caregiver has severe and unstable cardiac, oncological, hepatic, renal, or other illnesses
  • Caregiver has a history of psychiatric illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Service Maladies neuromusculaires et SLA

Marseille, France, 13005

Actively Recruiting

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Research Team

A

Annie Verschueren

CONTACT

A

Annie Verschueren

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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Anticipated Patient and Caregiver Burden | DecenTrialz