NCT05498883Completed
Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 93 (actual)
- First submitted
- 11 Aug 2022
- Start date
- 13 Sept 2022
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05498883
What you commit to
- Study type: Interventional
- Participants enrolled: 93
- From 13 Sept 2022 to the primary completion date, 3 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe cognitive impairment, particularly in relation to frontotemporal degeneration
Other
- Patients :
- Patient under legal protection/ guardianship
- insufficient command of French
- No indication criteria for NIV.
- Caregivers :
- insufficient command of French
- Caregiver of a patient with another chronic pathology
Who the study is looking for
- 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 :
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.