Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families

Обзор

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is two to three years. The patient physical and psychological sufferings in ALS are immense, and apart from Riluzole, there is no effective treatment. Care of advanced ALS have an estimated cost of 4-8 million NOK per year. Perhaps the most challenging topic of ALS care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. In these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (TIV) or non-invasive (NIV) modality. The present study is a longitudinal questionnaire study in Norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in ALS patients, partners and children before and after the introduction of life sustaining ventilation support. The investigators aim to increase the knowledge on how life-sustaining ventilation support with NIV or TIV affects the quality of life in ALS patients, life partners and children. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. The investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.

Вмешательства

• Устройство Long term mechanical ventilation support
  Patients that choose life prolonging treatment with long term mechanical ventilation support
• Устройство No long term mechanical ventilation support
  Patients that decline life prolonging treatment with long term mechanical ventilation support

Первичные конечные точки

• Overall quality of life assessed by the "Quality of Life Scale" [Срок оценки: At inclusion]
• Overall quality of life assessed by the "Quality of Life Scale" [Срок оценки: 3 months after inclusion]
• Overall quality of life assessed by the "Quality of Life Scale" [Срок оценки: 9 months after inclusion]
• Overall quality of life assessed by the "Quality of Life Scale" [Срок оценки: 15 months after inclusion]
• Overall quality of life assessed by the "Quality of Life Scale" [Срок оценки: 21 months after inclusion]

Вторичные конечные точки (12)

• Health-related quality of life assessed by the "EQ-5D-5L" [Срок оценки: At inclusion]
• Health-related quality of life assessed by the "EQ-5D-5L" [Срок оценки: 3 months after inclusion]
• Health-related quality of life assessed by the "EQ-5D-5L" [Срок оценки: 9 months after inclusion]
• Health-related quality of life assessed by the "EQ-5D-5L" [Срок оценки: 15 months after inclusion]
• Health-related quality of life assessed by the "EQ-5D-5L" [Срок оценки: 21 months after inclusion]
• Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Срок оценки: At inclusion]
• Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Срок оценки: 3 months after inclusion]
• Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Срок оценки: 9 months after inclusion]
• Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Срок оценки: 15 months after inclusion]
• Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Срок оценки: 21 months after inclusion]
• Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire" [Срок оценки: At inclusion]
• Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire" [Срок оценки: 3 months after inclusion]

Критерии участия

Inclusion criteria for patients:

• A clinical diagnosis of probable ALS according to the revised El Escorial criteria
• Progression of the illness leading the consulting physician to offer treatment with LTMV
• Can communicate in Norwegian

Inclusion criteria for partners of ALS patients:

• Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV
• Can communicate in Norwegian

Inclusion criteria for children:

• Children from 8 years and older having a parent who suffers from ALS with progression of the illness leading the consulting physician to offer treatment with LTMV
• Can communicate in Norwegian

Exclusion criteria for patients, partners and children of ALS patients:

1\. Potential participants with cognitive impairment or dementia.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 9 центров

• Nordland Hospital Bodø — Bodø
• Sørlandet Hospital Trust — Kristiansand
• Haukeland University Hospital — Bergen
• Akershus University Hospital — Lørenskog
• Oslo University Hospital — Oslo
• Østfold Hospital Kalnes — Sarpsborg
• Stavanger University Hospital — Stavanger
• Universitetssykehuset Nord-Norge — Tromsø
• … и ещё 1 центр

Идентификаторы

NCT: NCT05744310 · 492102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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