ALSVNI_SLANCT05621213
Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation
A study testing Teleconsultation assisted by a physiotherapist or nurse in people with ALS and Charcot Disease, run by AGIR à Dom at 2 sites in France.
Trial summary
Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS, Charcot Disease
- What is being tested?
- Teleconsultation assisted by a physiotherapist or nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Jan 2023to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a diagnosis of ALS coming for a follow-up consultation with their pneumologist
- Daily NIV compliance of more than 4 hours in the month prior to inclusion
- 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
Who cannot join
- Patient not available or wishing to change region within 3 months of inclusion
- Patient currently participating or having participated in the month prior to inclusion in another clinical interventional research study that may have an impact on the study, this impact is left to the discretion of the investigator
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Grenoble Alpes
Grenoble, France, 38043
CHU Montpellier
Montpellier, France, 34295
About this study
Official title: Satisfaction of Patients With Amyotrophic Lateral Sclerosis Under Non-invasive Ventilation Regarding Home Assisted Teleconsultation
Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultation
Read the detailed description
Amyotrophic Lateral Sclerosis (ALS) is a progressive and rapidly progressing neurodegenerative disease. Depending on the degree of muscle damage, patients may suffer from reduced mobility, difficulty swallowing, speech difficulties and finally respiratory weakness. Death occurs within an average of 2-3 years and is usually due to respiratory failure. Currently there is no cure for ALS, so palliative care and symptomatic treatments are essential for the management of these patients.
The gold standard treatment for respiratory impairment is non-invasive ventilation (NIV). The aim of this mask ventilation is to improve gas exchange by compensating for the weakness of the respiratory muscles.
The progressive nature of ALS requires regular assessment of the patient's clinical condition and evaluation of NIV parameters. Regular medical appointments are therefore essential to ensure optimal ventilation and close surveillance of the patient. A day hospitalization or a consultation is organized every 3 or 4 months. These visits can cause significant fatigue, not only because of the difficulty patients have to move around but also because of the time spent waiting in hospital.
ALS is characterised by its severity and it requires our society to think about and implement new ways of managing the disease. Thus, e-health innovations could be an interesting potential in the remote follow-up of these patients, to reduce the burden of hospital consultations.
The hypothesis is that the patient will be more satisfied with a home assisted teleconsultation follow-up, while keeping the same quality of non-invasive nocturnal ventilatory assistance.
- Conditions
- ALS, Charcot Disease
- Being tested
- Teleconsultation assisted by a physiotherapist or nurse
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleconsultation assisted by a physiotherapist or nurseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients who will be followed up by teleconsultation assisted by a physiotherapist or a nurse at home. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between the initial visit and the 3-month visit
Secondary outcomes (23)
Evolution of the patient's physical functions
Change in ALS-FRS-R (Amyotrophic lateral sclerosis functional rating scale revised) questionnaire score, score 0-48. The higher the score, the better the patient's physical function.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by S3-NIV (symptoms, sleep quality and side-effects related to the non-invasiv ventilation) questionnaire score 0-10. the higher the score, the fewer ALS-related symptoms the patient has.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by mean nocturnal oxygen saturation (SpO2, %) measured by oximetry
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by time spent (in minutes) below 90% SpO2, measured by oximetry
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by mean PtCO2 (in mmHg), measured by capnography
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by time spent (in minutes) above 50 mmHg PtCO2 measured by capnography
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by the treatment compliance (average daily use) through telemonitoring of the data recorded by the CPAP machine.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by the unintentional leakage through telemonitoring of the data recorded by the CPAP machine.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by the residual Apnea-Hypopnea Index (AHI) through telemonitoring of the data recorded by the CPAP machine.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the evolution of ventilation efficiency assessed from clinical parameters measured by S3-NIV (symptoms, sleep quality and side-effects related to the non-invasiv ventilation) questionnaire, score 0-10. the higher the score, the fewer ALS-related symptoms the patient has.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the evolution of ventilation efficiency assessed from mean PtCO2 (in mmHg), measured by capnography
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the evolution of ventilation efficiency assessed from time spent (in minutes) below 90% SpO2, measured by oximetry
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the evolution of ventilation efficiency assessed from mean nocturnal oxygen saturation (SpO2,%) measured by oximetry
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the evolution of ventilation efficiency assessed from time spent (in minutes) above 50 mmHg PtCO2 measured by capnography
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the evolution of ventilation efficiency assessed by the treatment compliance (average daily use) through telemonitoring of the data recorded by the CPAP machine.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the evolution of ventilation efficiency assessed by the unintentional leakage through telemonitoring of the data recorded by the CPAP machine.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the evolution of ventilation efficiency assessed by the residual Apnea-Hypopnea Index (AHI) through telemonitoring of the data recorded by the CPAP machine.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Patient satisfaction with teleconsultation itself (use and patient/doctor interaction)
Evaluation of the score of the Visit Satisfaction Questionnaire (VSQ-VF) score 0-100. The higher the score, the more satisfied the patient is.
Measured: After each teleconsultation (3-month visit and 6-month visit)
The evolution of satisfaction between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Comparison of the variation in the score of the visit satisfaction questionnaire, assessed by the VSQ-VF questionnaire, score 0-100. The higher the score, the more satisfied the patient is.
Measured: Between the 3-month visit, and the 6-months visit
Physician satisfaction with teleconsultation
Evaluation made by Visual Analogue Scale (VAS) from 0 to 10 cm. The higher the score, the more satisfied the physician is.
Measured: After each teleconsultation (3-month visit and 6-month visit)
Caregivers' satisfaction with the care of the relative
Change in caregiver satisfaction measured with client satisfaction questionnaire score (CSQ-8 modified) with 8 items, score 8-32. The higher the score, the more satisfied the caregivers' is.
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
The feasibility of home teleconsultation for ALS patients
Number of failed teleconsultations requiring rescheduling
Measured: Between the initial visit, the 3-month visit, and the 6-months visit
Retention of follow-up modality
Number of patients who changed follow-up modality, assessed by the number of face-to-face follow-up
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start13 Jan 2023
- Primary completion31 Dec 2024
- Study completion5 Sep 2025
Why it stopped: The study was terminated early due to insufficient recruitment despite mitigation measures, as enrolment rates could not meet protocol objectives. Academic thesis scheduling constraints also contributed. No safety concerns were identified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patient assigned to the interventional group or to the control group if they do not wish to be followed up by teleconsultation
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christel Saint-Raymond, PhD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621213
- Sponsor's protocol ID
- 2022-A01667-36
- Acronym
- VNI_SLA
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2022
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction of Patients With Amyotrophic Lateral Sclerosis Under Non-invasive Ventilation Regarding Home Assisted Teleconsultation
- ClinicalTrials.gov ID
- NCT05621213
- Acronym / sponsor ID
- VNI_SLA / 2022-A01667-36
- Conditions
- ALS, Charcot Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to insufficient recruitment despite mitigation measures, as enrolment rates could not meet protocol objectives. Academic thesis scheduling constraints also contributed. No safety concerns were identified.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultation
Detailed description
Amyotrophic Lateral Sclerosis (ALS) is a progressive and rapidly progressing neurodegenerative disease. Depending on the degree of muscle damage, patients may suffer from reduced mobility, difficulty swallowing, speech difficulties and finally respiratory weakness. Death occurs within an average of 2-3 years and is usually due to respiratory failure. Currently there is no cure for ALS, so palliative care and symptomatic treatments are essential for the management of these patients.
The gold standard treatment for respiratory impairment is non-invasive ventilation (NIV). The aim of this mask ventilation is to improve gas exchange by compensating for the weakness of the respiratory muscles.
The progressive nature of ALS requires regular assessment of the patient's clinical condition and evaluation of NIV parameters. Regular medical appointments are therefore essential to ensure optimal ventilation and close surveillance of the patient. A day hospitalization or a consultation is organized every 3 or 4 months. These visits can cause significant fatigue, not only because of the difficulty patients have to move around but also because of the time spent waiting in hospital.
ALS is characterised by its severity and it requires our society to think about and implement new ways of managing the disease. Thus, e-health innovations could be an interesting potential in the remote follow-up of these patients, to reduce the burden of hospital consultations.
The hypothesis is that the patient will be more satisfied with a home assisted teleconsultation follow-up, while keeping the same quality of non-invasive nocturnal ventilatory assistance.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient assigned to the interventional group or to the control group if they do not wish to be followed up by teleconsultation
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Teleconsultation assisted by a physiotherapist or nursePatients who will be followed up by teleconsultation assisted by a physiotherapist or a nurse at home. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with a diagnosis of ALS coming for a follow-up consultation with their pneumologist
- Daily NIV compliance of more than 4 hours in the month prior to inclusion
- Living at home
- Patient with a natural caregiver
- Patient equipped with computer equipment adapted for teleconsultation (tablet, computer, telephone... with an internet connection)
Key exclusion criteria (6 listed)
- Patient not available or wishing to change region within 3 months of inclusion
- Patient currently participating or having participated in the month prior to inclusion in another clinical interventional research study that may have an impact on the study, this impact is left to the discretion of the investigator
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teleconsultation assisted by a physiotherapist or nurseA 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. | Other | Intervention |
Primary outcome
Satisfaction of ALS patients followed by teleconsultation at home
Time frame: Between the initial visit and the 3-month visit
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.
23 secondary outcomes
Evolution of the patient's physical functions
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Non-inferiority of ventilatory efficiency compared to conventional management
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Patient satisfaction with teleconsultation itself (use and patient/doctor interaction)
Time frame: After each teleconsultation (3-month visit and 6-month visit)
The evolution of satisfaction between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
Time frame: Between the 3-month visit, and the 6-months visit
Physician satisfaction with teleconsultation
Time frame: After each teleconsultation (3-month visit and 6-month visit)
Caregivers' satisfaction with the care of the relative
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
The feasibility of home teleconsultation for ALS patients
Time frame: Between the initial visit, the 3-month visit, and the 6-months visit
Retention of follow-up modality
Time frame: At 6 months
Results and safety
The study was stopped early (reason given: The study was terminated early due to insufficient recruitment despite mitigation measures, as enrolment rates could not meet protocol objectives. Academic thesis scheduling constraints also contributed. No safety concerns were identified.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christel Saint-Raymond, PhD principal investigator
CHU Grenoble Alpes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation assisted by a physiotherapist or nurse in people with ALS and Charcot Disease, run by AGIR à Dom at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to insufficient recruitment despite mitigation measures, as enrolment rates could not meet protocol objectives. Academic thesis scheduling constraints also contributed. No safety concerns were identified.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of ALS patients followed by teleconsultation at home (time frame: Between the initial visit and the 3-month visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.