Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation

NCT05621213 | Terminated

• 1 other identifier: 2022-A01667-36
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultation

Conditions

ALS; Charcot Disease

Outcome Measures

Primary Outcomes (1)

• Satisfaction of ALS patients followed by teleconsultation at home

  Evolution of the overall satisfaction score obtained from the Client Satisfaction Questionnaire CSQ-8, with 8 items, score 8-32. The higher the score, the more satisfied the patient is.

  Between the initial visit and the 3-month visit

Secondary Outcomes (23)

• Evolution of the patient's physical functions

  Between the initial visit, the 3-month visit, and the 6-months visit

• Non-inferiority of ventilatory efficiency compared to conventional management

  Between the initial visit, the 3-month visit, and the 6-months visit

• Non-inferiority of ventilatory efficiency compared to conventional management

  Between the initial visit, the 3-month visit, and the 6-months visit

• Non-inferiority of ventilatory efficiency compared to conventional management

  Between the initial visit, the 3-month visit, and the 6-months visit

• Non-inferiority of ventilatory efficiency compared to conventional management

  Between the initial visit, the 3-month visit, and the 6-months visit

Study Arms (2)

Intervention

EXPERIMENTAL

Patients who will be followed up by teleconsultation assisted by a physiotherapist or a nurse at home.

Other: Teleconsultation assisted by a physiotherapist or nurse

Control group

NO INTERVENTION

Patients not wishing to be followed up by teleconsultation but agreeing to participate in the study and the collection of questionnaires. They will follow up as usual in person (no teleconsultation).

Interventions

Teleconsultation assisted by a physiotherapist or nurse OTHER

A home health care provider (with expertise in NIV) will be asked to attend the 2 home teleconsultation sessions. This assistance will make it possible to help, if necessary, the patient to settle in and connect, collect the elements necessary for the doctor's consultation and adjust, if necessary, the NIV settings. He will also be responsible for administering the questionnaires to the patient as well as to his family caregiver.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a diagnosis of ALS coming for a follow-up consultation with their pneumologist
• Living at home
• Patient with a natural caregiver
• Patient equipped with computer equipment adapted for teleconsultation (tablet, computer, telephone... with an internet connection)
• Patient able to read and understand the procedure, and able to express consent for the study protocol
• Patient, or his or her caregiver, able to sign the consent to participate by himself or herself

You may not qualify if:

• Persons referred to in articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons)
• Pregnant women (for women of childbearing age and in the absence of reliable contraception, the β-HCG (human chorionic gonadotropin) assay will be performed), parturient women, breastfeeding women,
• persons deprived of their liberty by judicial or administrative decision,
• persons under legal protection

Sponsors & Collaborators

• AGIR à Dom: lead

Study Sites (2)

CHU Grenoble Alpes

Grenoble, France, 38043, France

Location

CHU Montpellier

Montpellier, France, 34295, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Nurses

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Christel Saint-Raymond, PhD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient assigned to the interventional group or to the control group if they do not wish to be followed up by teleconsultation

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 17, 2022
• Study Start: January 13, 2023
• Primary Completion: December 31, 2024
• Study Completion: September 5, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (2)