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

"Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home." Tele Monitoring Ventilation At Home (TM-VAH)

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis; Noninvasive Ventilation
• Intervention / Treatment: Other: teleconsultation

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction of the telemonitoring of non invasive ventilation at home assessed by CSQ-8 at the end of the study	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of remote monitoring	evaluated by teleconsultation	every 3 months during 1 year
Patient satisfaction during the study	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.	every 3 months during 1 year
Feasibility for caregivers assessed by Zarit questionnaire	Painfulness or burden assessment scale. Minimal score is 0 and maximal score is 76. the higher the score, the greater the difficulty.	every 3 months during 1 year
Feasibility for caregivers assessed by Depression Anxiety Stress Scales (DASS-21) questionnaire	Painfulness or burden assessment scale. Minimal score is 0 and maximal score is 63. the higher the score, the greater the depression.	every 3 months during 1 year
Feasibility for nursing staff	data collected through remote monitoring	every 3 months during 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Sandrine Pontier-Marchandise, MD, University Hopsital Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Telemonitoring; noninvasive ventilation; feasibility; amyotrophic lateral sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: RC31/20/0477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No