Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home.

Amyotrophic Lateral Sclerosis Clinical Trial

— TS-VAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797845
• Other study ID #: RC31/20/0477
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: September 18, 2023

Study information

• Verified date: June 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Noninvasive Ventilation
• Sclerosis

Intervention

Other:
• teleconsultation
Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months.

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of remote monitoring	evaluated by teleconsultation	every 3 months during 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Feasibility for nursing staff	data collected through remote monitoring	every 3 months during 1 year