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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorHaukeland University Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Long term mechanical ventilation support

    Device

    Patients that choose life prolonging treatment with long term mechanical ventilation support

  • No long term mechanical ventilation support

    Device

    Patients that decline life prolonging treatment with long term mechanical ventilation support

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ALS patients that choose life prolonging treatment with LTMV and their familiesActive comparator 1 intervention
Group B: ALS patients that decline life prolonging treatment with LTMV and their familiesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall quality of life assessed by the "Quality of Life Scale"

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

Time frame
At inclusion
2

Overall quality of life assessed by the "Quality of Life Scale"

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

Time frame
3 months after inclusion
3

Overall quality of life assessed by the "Quality of Life Scale"

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

Time frame
9 months after inclusion
4

Overall quality of life assessed by the "Quality of Life Scale"

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

Time frame
15 months after inclusion

Secondary outcomes

1

Health-related quality of life assessed by the "EQ-5D-5L"

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

Time frame
At inclusion
2

Health-related quality of life assessed by the "EQ-5D-5L"

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

Time frame
3 months after inclusion
3

Health-related quality of life assessed by the "EQ-5D-5L"

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

Time frame
9 months after inclusion
4

Health-related quality of life assessed by the "EQ-5D-5L"

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

Time frame
15 months after inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haukeland University Hospital

Lead sponsor

Oslo University Hospital

Collaborator

University Hospital, Akershus

Collaborator

Helse Stavanger HF

Collaborator

University Hospital of North Norway

Collaborator

St. Olavs Hospital

Collaborator

Nordland Hospital, Bodø

Collaborator

Hospital of Southern Norway Kristiansand

Collaborator

Østfold Hospital Kalnes

Collaborator