Amyotrophic Lateral SclerosisTS-VADNCT04797845
Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home.
A study testing teleconsultation in people with Amyotrophic Lateral Sclerosis and Noninvasive Ventilation, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Noninvasive Ventilation
- What is being tested?
- teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2021to 18 Sep 2023
- 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
- 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
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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.
- Being tested
- teleconsultation
- Keywords
- Telemonitoring, amyotrophic lateral sclerosis, noninvasive ventilation, feasibility
- 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.
teleconsultationOther
Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months.
| Study group | Role | What they receive |
|---|---|---|
| telemonitoring of non invasive ventilation at home | Experimental | 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. Receives: Other: teleconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Effect of remote monitoring
evaluated by teleconsultation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: every 3 months during 1 year
Feasibility for nursing staff
data collected through remote monitoring
Measured: every 3 months during 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start12 Apr 2021
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine Pontier-Marchandise, MD, Principal investigator, University Hopsital Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797845
- Sponsor's protocol ID
- RC31/20/0477
- Acronym
- TS-VAD
- Status last verified
- Jun 2024
- First submitted
- 3 Feb 2021
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home." Tele Monitoring Ventilation At Home (TM-VAH)
- ClinicalTrials.gov ID
- NCT04797845
- Acronym / sponsor ID
- TS-VAD / RC31/20/0477
- Keywords
- Telemonitoring, amyotrophic lateral sclerosis, noninvasive ventilation, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 15 Mar 2021 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telemonitoring of non invasive ventilation at home | Experimental | Other: teleconsultationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| teleconsultationPatients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months. | Other | telemonitoring of non invasive ventilation at home |
Primary outcome
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.
5 secondary outcomes
Effect of remote monitoring
Time frame: every 3 months during 1 year
Patient satisfaction during the study
Time frame: every 3 months during 1 year
Feasibility for caregivers assessed by Zarit questionnaire
Time frame: every 3 months during 1 year
Feasibility for caregivers assessed by Depression Anxiety Stress Scales (DASS-21) questionnaire
Time frame: every 3 months during 1 year
Feasibility for nursing staff
Time frame: every 3 months during 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Sandrine Pontier-Marchandise, MD principal investigator
University Hopsital Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing teleconsultation in people with Amyotrophic Lateral Sclerosis and Noninvasive Ventilation, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 17 Jun 2024.