Clinical trial NCT05744310: Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families
Official title: Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Nervous System Diseases
Spinal Cord Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Keywords: Quality of life
Overall quality of life
Health related quality of life
Disease specific quality of life
Ventilation support
Non-invasive ventilation support
Invasive ventilation support
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University Hospital, Akershus
name: Helse Stavanger HF
name: University Hospital of North Norway
name: St. Olavs Hospital
First posted: 2023-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria for patients:

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

Inclusion criteria for partners of ALS patients:

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

Inclusion criteria for children:

1. 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
2. Can communicate in Norwegian

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

1. Potential participants with cognitive impairment or dementia.

Primary outcomes:
measure: Overall quality of life assessed by the "Quality of Life Scale"
timeFrame: At inclusion
measure: Overall quality of life assessed by the "Quality of Life Scale"
timeFrame: 3 months after inclusion
measure: Overall quality of life assessed by the "Quality of Life Scale"
timeFrame: 9 months after inclusion
measure: Overall quality of life assessed by the "Quality of Life Scale"
timeFrame: 15 months after inclusion
measure: Overall quality of life assessed by the "Quality of Life Scale"
timeFrame: 21 months after inclusion
Secondary outcomes:
measure: Health-related quality of life assessed by the "EQ-5D-5L"
timeFrame: At inclusion
measure: Health-related quality of life assessed by the "EQ-5D-5L"
timeFrame: 3 months after inclusion
measure: Health-related quality of life assessed by the "EQ-5D-5L"
timeFrame: 9 months after inclusion
measure: Health-related quality of life assessed by the "EQ-5D-5L"
timeFrame: 15 months after inclusion
measure: Health-related quality of life assessed by the "EQ-5D-5L"
timeFrame: 21 months after inclusion
measure: Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
timeFrame: At inclusion
measure: Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
timeFrame: 3 months after inclusion
measure: Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
timeFrame: 9 months after inclusion
measure: Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
timeFrame: 15 months after inclusion
measure: Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
timeFrame: 21 months after inclusion
measure: Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
timeFrame: At inclusion
measure: Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
timeFrame: 3 months after inclusion
measure: Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
timeFrame: 9 months after inclusion
measure: Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
timeFrame: 15 months after inclusion
measure: Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
timeFrame: 21 months after inclusion
measure: Health-related quality of life assessed by "Kidsscreen-27"
timeFrame: At inclusion
measure: Health-related quality of life assessed by "Kidsscreen-27"
timeFrame: 3 months after inclusion
measure: Health-related quality of life assessed by "Kidsscreen-27"
timeFrame: 9 months after inclusion
measure: Health-related quality of life assessed by "Kidsscreen-27"
timeFrame: 15 months after inclusion
measure: Health-related quality of life assessed by "Kidsscreen-27"
timeFrame: 21 months after inclusion
measure: Caregiver burden assessed by "Zarit Burden Interview"
timeFrame: At inclusion
measure: Caregiver burden assessed by "Zarit Burden Interview"
timeFrame: 3 months after inclusion
measure: Caregiver burden assessed by "Zarit Burden Interview"
timeFrame: 9 months after inclusion
measure: Caregiver burden assessed by "Zarit Burden Interview"
timeFrame: 15 months after inclusion
measure: Caregiver burden assessed by "Zarit Burden Interview"
timeFrame: 21 months after inclusion
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nordland Hospital Bodø
state: Nordland
city: Kristiansand
country: Norway
facility: Sørlandet Hospital Trust
state: Vest Agder
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Sarpsborg
country: Norway
facility: Østfold Hospital Kalnes
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Ole-Bjørn Tysnes
role: PRINCIPAL_INVESTIGATOR
References: