Amyotrophic Lateral SclerosisQuality EvALSNCT05498883
Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation
A study testing Score completion in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Score completion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2022to 3 Jul 2024
- 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
- Patients :
- 18 years or more
- Patient followed for ALS probable or certain with Awaji criteria
- group 1 : severe chronic respiratory failure, with a decision by the attending physician to start NIV
- group 2 : complete dependence on NIV
- Caregivers :
Show all 11Show fewer
- 18 years or more
- Informed and does not object to the study
- Primary caregiver for more than 3 months of an ALS patient on NIV (either at initiation or with 24 hours NIV dependence)
- More than 30 hours spent at home per week
- Met the inclusion criteria for group 1 (NIV initiation) or group 2 (24 hours NIV dependence)
Who cannot join
- Patients :
- Patient under legal protection/ guardianship
- insufficient command of French
- Severe cognitive impairment, particularly in relation to frontotemporal degeneration
- No indication criteria for NIV.
- Caregivers :
- insufficient command of French
- Caregiver of a patient with another chronic pathology
Trial locations and contacts
1 site in 1 country.
France1 site
Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université
Paris, Paris, 75013
About this study
This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV
This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations
Read the detailed description
The course of the study is as follows:
Patient newly ventilated with NIV :
inclusion is done on the day of starting NIV. On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.
For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month and six-month follow-up
Patient dependent of NIV :
On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.
For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month follow-up
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Score completion
- Keywords
- amyotrophic lateral sclerosis, quality of life evaluation, SRI questionnaire, Zarit Burden interview
- 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.
Score completionOther
completion of the SRI score
| Study group | Role | What they receive |
|---|---|---|
| patient requiring NIV | Other | Clinical examination, completion of the ALS-FRS score, completion of the SRI score. Receives: Other: Score completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRI questionnaire in patients who have indication for starting NIV
SRI questionnaire assessment at initiation of NIV, at 3-month follow-up and at 6-month follow-up
Measured: six months
Secondary outcomes (2)
SRI of patients with total ventilatory dependence in ALS
SRI questionnaire assessment at inclusion and at 3-month follow-up
Measured: three months
Zarit burden interview in both groups
Zarit Burden interview questionnaire in ALS patient caregiver, in both groups (initiation of NIV and NIV-dependent patients) at inclusion, 3-month follow-up (both groups) and at 6-month follow-up (in group 1)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start13 Sep 2022
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
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 Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Capucine Pr MORELOT PANZINI, MD PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498883
- Sponsor's protocol ID
- APHP220697
- Acronym
- Quality EvALS
- Status last verified
- Sep 2024
- First submitted
- 11 Aug 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation
- ClinicalTrials.gov ID
- NCT05498883
- Acronym / sponsor ID
- Quality EvALS / APHP220697
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, quality of life evaluation, SRI questionnaire, Zarit Burden interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 12 Aug 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.
This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV
This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations
Detailed description
The course of the study is as follows:
Patient newly ventilated with NIV :
inclusion is done on the day of starting NIV. On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.
For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month and six-month follow-up
Patient dependent of NIV :
On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.
For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month follow-up
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient requiring NIV | Other | Other: Score completionClinical examination, completion of the ALS-FRS score, completion of the SRI score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years or more
- Patient followed for ALS probable or certain with Awaji criteria
- group 1 : severe chronic respiratory failure, with a decision by the attending physician to start NIV
- group 2 : complete dependence on NIV
- 18 years or more
Key exclusion criteria (8 listed)
- Patient under legal protection/ guardianship
- insufficient command of French
- Severe cognitive impairment, particularly in relation to frontotemporal degeneration
- No indication criteria for NIV.
- insufficient command of French
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 |
|---|---|---|
| Score completioncompletion of the SRI score | Other | patient requiring NIV |
Primary outcome
SRI questionnaire in patients who have indication for starting NIV
Time frame: six months
SRI questionnaire assessment at initiation of NIV, at 3-month follow-up and at 6-month follow-up
2 secondary outcomes
SRI of patients with total ventilatory dependence in ALS
Time frame: three months
Zarit burden interview in both groups
Time frame: Six months
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Capucine Pr MORELOT PANZINI, MD PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Score completion in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique - Hôpitaux de Paris 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?
The sponsor lists 11 inclusion and 8 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: finished, as of the sponsor's last update on 19 Sep 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?
SRI questionnaire in patients who have indication for starting NIV (time frame: six months). 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 19 Sep 2024.