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Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home. (TS-VAD)

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ClinicalTrials.gov Identifier: NCT04797845
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Single-center, prospective pilot study on patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. The objective is to assess the satisfaction of remote monitoring of patients on non-invasive ventilation after 12 months.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Noninvasive Ventilation Other: teleconsultation Not Applicable

Detailed Description:
The non invasive ventilation is one of treatments used during the amyotrophic lateral sclerosis when patients have a chronic respiratory failure with alveolar hypoventilation signs. It is demonstrated to improve quality of life and prognosis of the disease. These patients, often severely disabled, generally have a negative experience of repeated hospitalizations. Despite everything, medical and paramedical monitoring is necessary, especially when they are fitted with non invasive ventilation (NIV). A quarterly reassessment is recommended . The possibilities of telemonitoring at home have grown considerably in recent years. In addition, the fans are currently able to remotely transfer a certain amount of data to the service provider, making remote monitoring feasible.Our project therefore aims to assess the feasibility of remote monitoring of patients with Amyotrophic Lateral Sclerosis (ALS) fitted with non invasive ventilation (NIV) through the assessment of their satisfaction, using both medical data and data provided by the ventilator. It is a single-center, prospective pilot study on 30 patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. Patients will benefit from a quarterly teleconsultation to assess the study criteria through questionnaires during 12 months. Ventilation machines make it possible to carry out remote monitoring, with the help of healthcare providers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: "Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home." Tele Monitoring Ventilation At Home (TM-VAH)
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : February 29, 2024
Estimated Study Completion Date : February 29, 2024


Arm Intervention/treatment
Experimental: telemonitoring of non invasive ventilation at home
Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months. Ventilation machines make it possible to carry out remote monitoring, with the help of healthcare providers.
Other: teleconsultation
Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months.




Primary Outcome Measures :
  1. Patient satisfaction of the telemonitoring of non invasive ventilation at home assessed by CSQ-8 at the end of the study [ Time Frame: 1 year ]
    Consumer satisfaction questionnaire (CSQ-8), minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.


Secondary Outcome Measures :
  1. Effect of remote monitoring [ Time Frame: every 3 months during 1 year ]
    evaluated by teleconsultation

  2. Patient satisfaction during the study [ Time Frame: every 3 months during 1 year ]
    assessed by Consumer satisfaction questionnaire (CSQ-8), minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.

  3. Feasibility for caregivers assessed by Zarit questionnaire [ Time Frame: every 3 months during 1 year ]
    Painfulness or burden assessment scale. Minimal score is 0 and maximal score is 76. the higher the score, the greater the difficulty.

  4. Feasibility for caregivers assessed by Depression Anxiety Stress Scales (DASS-21) questionnaire [ Time Frame: every 3 months during 1 year ]
    Painfulness or burden assessment scale. Minimal score is 0 and maximal score is 63. the higher the score, the greater the depression.

  5. Feasibility for nursing staff [ Time Frame: every 3 months during 1 year ]
    data collected through remote monitoring



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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

o inclusion criteria:

  • Patient over 18 years,
  • Patient with Amyotrophic Lateral Sclerosis (ALS),
  • Already fitted by Non Invasive Ventilation (NIV),
  • Patient having signed the informed consent
  • Patient affiliated to a social security scheme,
  • Patient with a correct understanding of the French language,
  • Patient with access to an internet connection at home.

For the caregiver:

  • Adult person
  • Be the patient's primary caregiver
  • Have signed the informed consent intended for the caregiver

    o exclusion criteria:

  • Patient with another cause of chronic respiratory failure: other neuromuscular diseases, Chronic obstructive pulmonary disease (COPD), diffuse interstitial lung disease,
  • Patient under guardianship or under judicial protection,
  • Patient dependent at least 20 hours out of 24 of the non invasive Ventilation (NIV).

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): NCT04797845


Contacts
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Contact: Sandrine Pontier-Marchandise, MD 05 67 77 18 46 pontier.s@chu-toulouse.fr

Locations
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France
Toulouse University Hospital Recruiting
Toulouse, France
Contact: Sandrine Pontier-Marchandise, Dr    05 67 77 18 46    pontier.s@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Sandrine Pontier-Marchandise, MD University Hopsital Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04797845    
Other Study ID Numbers: RC31/20/0477
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 University Hospital, Toulouse:
Telemonitoring
amyotrophic lateral sclerosis
noninvasive ventilation
feasibility
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