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Effecten van langdurige beademingsondersteuning op de levenskwaliteit van ALS-patiënten en hun families (ALS-LTMV)

16 september 2026 bijgewerkt door: Haukeland University Hospital

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Noorwegen
      • Bergen, Noorwegen
      • Lørenskog, Noorwegen
        • Werving
        • Akershus University Hospital
        • Hoofdonderzoeker:
          • Ola Nakken
        • Contact:
          • Ola Nakken
      • Oslo, Noorwegen
        • Werving
        • Oslo University Hospital
        • Hoofdonderzoeker:
          • Angelina Maniaol
        • Contact:
          • Angelina Maniaol
      • Sarpsborg, Noorwegen, 1714
        • Nog niet aan het werven
        • Østfold Hospital Kalnes
        • Contact:
      • Stavanger, Noorwegen
        • Werving
        • Stavanger University Hospital
        • Hoofdonderzoeker:
          • Katrin Ruth Schlüter
        • Contact:
          • Katrin Ruth Schlüter
      • Tromsø, Noorwegen
        • Werving
        • Universitetssykehuset Nord-Norge
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Agnethe Eltoft, MD
        • Hoofdonderzoeker:
          • Monica Vold, MD
      • Trondheim, Noorwegen
        • Werving
        • St. Olavs Hospital
        • Contact:
          • Eivind Brønstad, MD PhD
        • Hoofdonderzoeker:
          • Eivind Brønstad, MD PhD
    • Nordland
    • Vest Agder
      • Kristiansand, Vest Agder, Noorwegen
        • Werving
        • Sørlandet Hospital Trust
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

8 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: ALS-patiënten die kiezen voor een levensverlengende behandeling met LTMV en hun families
Apparaat: Long term mechanical ventilation support

Patients that choose life prolonging treatment with long term mechanical ventilation support
Actieve vergelijker: ALS-patiënten die een levensverlengende behandeling met LTMV weigeren en hun families
Apparaat: No long term mechanical ventilation support

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall quality of life assessed by the "Quality of Life Scale"
Tijdsspanne: At inclusion

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
At inclusion
Overall quality of life assessed by the "Quality of Life Scale"
Tijdsspanne: 3 months after inclusion

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
3 months after inclusion
Overall quality of life assessed by the "Quality of Life Scale"
Tijdsspanne: 9 months after inclusion

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
9 months after inclusion
Overall quality of life assessed by the "Quality of Life Scale"
Tijdsspanne: 15 months after inclusion

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
15 months after inclusion
Overall quality of life assessed by the "Quality of Life Scale"
Tijdsspanne: 21 months after inclusion

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Health-related quality of life assessed by the "EQ-5D-5L"
Tijdsspanne: At inclusion

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
At inclusion
Health-related quality of life assessed by the "EQ-5D-5L"
Tijdsspanne: 3 months after inclusion

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
3 months after inclusion
Health-related quality of life assessed by the "EQ-5D-5L"
Tijdsspanne: 9 months after inclusion

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
9 months after inclusion
Health-related quality of life assessed by the "EQ-5D-5L"
Tijdsspanne: 15 months after inclusion

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
15 months after inclusion
Health-related quality of life assessed by the "EQ-5D-5L"
Tijdsspanne: 21 months after inclusion

"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
21 months after inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Tijdsspanne: At inclusion

"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
At inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Tijdsspanne: 3 months after inclusion

"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
3 months after inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Tijdsspanne: 9 months after inclusion

"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
9 months after inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Tijdsspanne: 15 months after inclusion

"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
15 months after inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Tijdsspanne: 21 months after inclusion

"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
21 months after inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Tijdsspanne: At inclusion

"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
At inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Tijdsspanne: 3 months after inclusion

"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
3 months after inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Tijdsspanne: 9 months after inclusion

"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
9 months after inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Tijdsspanne: 15 months after inclusion

"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
15 months after inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Tijdsspanne: 21 months after inclusion

"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
21 months after inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Tijdsspanne: At inclusion

"Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.
At inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Tijdsspanne: 3 months after inclusion

"Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.
3 months after inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Tijdsspanne: 9 months after inclusion

"Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.
9 months after inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Tijdsspanne: 15 months after inclusion

"Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.
15 months after inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Tijdsspanne: 21 months after inclusion

"Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.
21 months after inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Tijdsspanne: At inclusion

"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
At inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Tijdsspanne: 3 months after inclusion

"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
3 months after inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Tijdsspanne: 9 months after inclusion

"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
9 months after inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Tijdsspanne: 15 months after inclusion

"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
15 months after inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Tijdsspanne: 21 months after inclusion

"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
21 months after inclusion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Haukeland University Hospital

Medewerkers

Oslo University Hospital
University Hospital of North Norway
Helse Stavanger HF
St. Olavs Hospital
University Hospital, Akershus
Nordland Hospital, Bodø
Hospital of Southern Norway Kristiansand
Østfold Hospital Kalnes

Onderzoekers

  • Hoofdonderzoeker: Ole-Bjørn Tysnes, Haukeland University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 april 2023

Primaire voltooiing (Geschat)

21 augustus 2032

Studie voltooiing (Geschat)

21 augustus 2032

Studieregistratiedata

Eerst ingediend

30 januari 2023

Eerst ingediend dat voldeed aan de QC-criteria

21 februari 2023

Eerst geplaatst (Werkelijk)

27 februari 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 492102

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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