search
Back to results

Anticipated Patient and Caregiver Burden (FARP)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychological assessments
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring amyotrophic lateral sclerosis, caregiver, burden, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service Maladies neuromusculaires et SLARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychological assessments

Arm Description

Outcomes

Primary Outcome Measures

Impact of the patient's sense of being a burden on the patient's suicidal ideation
Columbia scale (highest score meaning better outcome)

Secondary Outcome Measures

Relationship between the patient's feeling of being a burden living
Patient's Feelings of Burden Scale (highest score meaning worst outcome)
Relationship between the patient's reasons for living
Patient Reasons for Living Scale (highest score meaning worst outcome)
Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship
Patient's sense of burden scale and Zarit Caregiver Exertion Scale
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
WHOQOL-Bref (World Health Organization Quality of Life, highest score meaning better outcome)
Relationship between the patient's feeling of being a burden and the motor disability
Beck scale (highest score meaning worse outcome)
Relationship between the patient's feeling of being a burden and the motor disability
Rankin scale (highest score meaning worse outcome)
Relationship between the patient's feeling of being a burden and the motor disability
ALSFRS score (highest score meaning better outcome)
Relationship between the depression of patient and the caregiver
Beck scale (highest score meaning worse outcome)
Relationship between the depression of patient and the caregiver
Rankin scale (highest score meaning worse outcome)
Relationship between the depression of patient and the caregiver
ALSFRS score (highest score meaning better outcome)
Impact of the caregiver's feeling of hardship on the patient's reasons for living
Patient Reasons for Living Scale (highest score meaning worst outcome)
Impact of the caregiver's feeling of hardship on the patient's reasons for living
Columbia Scale (highest score meaning better outcome)
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
Patient Reasons for Living Scale (highest score meaning worst outcome)
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
Columbia Scale (highest score meaning better outcome)
Relationship between the caregiver's perceived distress and the patient's suicidal ideation
Zarit scale (highest score meaning worse outcome)
Relationship between the caregiver's perceived distress and the patient's suicidal ideation
Columbia Scale (highest score meaning better outcome)
Relationship between caregiver's perceived distress and the patient's cognitive assessment
ECAS score (Cognitif Edinburgh Cognitive and Behavioural ALS Screen) (highest score meaning better outcome)

Full Information

First Posted
November 16, 2022
Last Updated
April 23, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT05632757
Brief Title
Anticipated Patient and Caregiver Burden
Acronym
FARP
Official Title
Anticipated Patient and Caregiver Burden: Impact in People With Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
amyotrophic lateral sclerosis, caregiver, burden, depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychological assessments
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Psychological assessments
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impact of the patient's sense of being a burden on the patient's suicidal ideation
Description
Columbia scale (highest score meaning better outcome)
Time Frame
Inclusion visit (month 0)
Secondary Outcome Measure Information:
Title
Relationship between the patient's feeling of being a burden living
Description
Patient's Feelings of Burden Scale (highest score meaning worst outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the patient's reasons for living
Description
Patient Reasons for Living Scale (highest score meaning worst outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship
Description
Patient's sense of burden scale and Zarit Caregiver Exertion Scale
Time Frame
Inclusion visit (month 0)
Title
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
Description
WHOQOL-Bref (World Health Organization Quality of Life, highest score meaning better outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the patient's feeling of being a burden and the motor disability
Description
Beck scale (highest score meaning worse outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the patient's feeling of being a burden and the motor disability
Description
Rankin scale (highest score meaning worse outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the patient's feeling of being a burden and the motor disability
Description
ALSFRS score (highest score meaning better outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the depression of patient and the caregiver
Description
Beck scale (highest score meaning worse outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the depression of patient and the caregiver
Description
Rankin scale (highest score meaning worse outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the depression of patient and the caregiver
Description
ALSFRS score (highest score meaning better outcome)
Time Frame
Inclusion visit (month 0)
Title
Impact of the caregiver's feeling of hardship on the patient's reasons for living
Description
Patient Reasons for Living Scale (highest score meaning worst outcome)
Time Frame
Inclusion visit (month 0)
Title
Impact of the caregiver's feeling of hardship on the patient's reasons for living
Description
Columbia Scale (highest score meaning better outcome)
Time Frame
Inclusion visit (month 0)
Title
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
Description
Patient Reasons for Living Scale (highest score meaning worst outcome)
Time Frame
Inclusion visit (month 0)
Title
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
Description
Columbia Scale (highest score meaning better outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the caregiver's perceived distress and the patient's suicidal ideation
Description
Zarit scale (highest score meaning worse outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between the caregiver's perceived distress and the patient's suicidal ideation
Description
Columbia Scale (highest score meaning better outcome)
Time Frame
Inclusion visit (month 0)
Title
Relationship between caregiver's perceived distress and the patient's cognitive assessment
Description
ECAS score (Cognitif Edinburgh Cognitive and Behavioural ALS Screen) (highest score meaning better outcome)
Time Frame
Inclusion visit (month 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Verschueren
Phone
0491386578
Ext
33
Email
annie.verschueren@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Verschueren
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annie Verschueren
Organizational Affiliation
AP-HM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service Maladies neuromusculaires et SLA
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Verschueren
Email
annie.verschueren@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anticipated Patient and Caregiver Burden

We'll reach out to this number within 24 hrs