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Quality of Life Evaluation With the SRI Questionnaire of ALS Patient With Non-invasive Ventilation (Quality EvALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05498883
Recruitment Status : Recruiting
First Posted : August 12, 2022
Last Update Posted : September 19, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV

This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Score completion Not Applicable

Detailed Description:

The course of the study is as follows:

Patient newly ventilated with NIV :

inclusion is done on the day of starting NIV. On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.

For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month and six-month follow-up

Patient dependent of NIV :

On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.

For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month follow-up

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Quality of Life Evaluation With the SRI Questionnaire of ALS Patient With Non-invasive Ventilation
Actual Study Start Date : September 13, 2022
Estimated Primary Completion Date : September 13, 2024
Estimated Study Completion Date : September 13, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
patient requiring NIV
Clinical examination, completion of the ALS-FRS score, completion of the SRI score.
 Other: Score completion
completion of the SRI score


Outcome Measures
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Primary Outcome Measures :
  1. SRI questionnaire in patients who have indication for starting NIV [ Time Frame: six months ]
    SRI questionnaire assessment at initiation of NIV, at 3-month follow-up and at 6-month follow-up


Secondary Outcome Measures :
  1. SRI of patients with total ventilatory dependence in ALS [ Time Frame: three months ]
    SRI questionnaire assessment at inclusion and at 3-month follow-up

  2. Zarit burden interview in both groups [ Time Frame: Six months ]
    Zarit Burden interview questionnaire in ALS patient caregiver, in both groups (initiation of NIV and NIV-dependent patients) at inclusion, 3-month follow-up (both groups) and at 6-month follow-up (in group 1)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients :

  • 18 years or more
  • Patient followed for ALS probable or certain with Awaji criteria
  • group 1 : severe chronic respiratory failure, with a decision by the attending physician to start NIV
  • group 2 : complete dependence on NIV

Caregivers :

  • 18 years or more
  • Informed and does not object to the study
  • Primary caregiver for more than 3 months of an ALS patient on NIV (either at initiation or with 24 hours NIV dependence)
  • More than 30 hours spent at home per week
  • Met the inclusion criteria for group 1 (NIV initiation) or group 2 (24 hours NIV dependence)

Exclusion Criteria:

Patients :

  • Patient under legal protection/ guardianship
  • insufficient command of French
  • Severe cognitive impairment, particularly in relation to frontotemporal degeneration
  • No indication criteria for NIV.

Caregivers :

  • insufficient command of French
  • Caregiver of a patient with another chronic pathology
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05498883


Contacts
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Contact: Capucine Pr MORELOT PANZINI, MD PhD +33 1 42 16 77 71 capucine.morelot@aphp.fr

Locations
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France
Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université Recruiting
Paris, France, 75013
Contact: Capucine Pr MORELOT-PANZINI, MD PhD    01 42 16 78 59 ext +33    capucine.morelot@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Capucine Pr MORELOT PANZINI, MD PhD APHP
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05498883    
Other Study ID Numbers: APHP220697
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
amyotrophic lateral sclerosis
quality of life evaluation
SRI questionnaire
Zarit Burden interview
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases