Menu
Recruiting NCT05744310

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

No phase Interventional Amyotrophic Lateral Sclerosis Motor Neuron Disease Nervous System Diseases Spinal Cord Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Long term mechanical ventilation support, No long term mechanical ventilation support.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Nervous System Diseases, Spinal Cord Diseases. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Overall quality of life assessed by the "Quality of Life Scale" [Time frame: At inclusion]
  • Overall quality of life assessed by the "Quality of Life Scale" [Time frame: 3 months after inclusion]
  • Overall quality of life assessed by the "Quality of Life Scale" [Time frame: 9 months after inclusion]
  • Overall quality of life assessed by the "Quality of Life Scale" [Time frame: 15 months after inclusion]
  • Overall quality of life assessed by the "Quality of Life Scale" [Time frame: 21 months after inclusion]
Secondary outcome measures (12)
  • Health-related quality of life assessed by the "EQ-5D-5L" [Time frame: At inclusion]
  • Health-related quality of life assessed by the "EQ-5D-5L" [Time frame: 3 months after inclusion]
  • Health-related quality of life assessed by the "EQ-5D-5L" [Time frame: 9 months after inclusion]
  • Health-related quality of life assessed by the "EQ-5D-5L" [Time frame: 15 months after inclusion]
  • Health-related quality of life assessed by the "EQ-5D-5L" [Time frame: 21 months after inclusion]
  • Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Time frame: At inclusion]
  • Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Time frame: 3 months after inclusion]
  • Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Time frame: 9 months after inclusion]
  • Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Time frame: 15 months after inclusion]
  • Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)" [Time frame: 21 months after inclusion]
  • Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire" [Time frame: At inclusion]
  • Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire" [Time frame: 3 months after inclusion]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 9 centers
  • 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
  • … and 1 more center

Identifiers

NCT: NCT05744310 · 492102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗