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Auswirkungen der langfristigen Beatmungsunterstützung auf die Lebensqualität von ALS-Patienten und ihren Familien (ALS-LTMV)

16. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Norwegen
      • Bergen, Norwegen
      • Lørenskog, Norwegen
        • Rekrutierung
        • Akershus University Hospital
        • Hauptermittler:
          • Ola Nakken
        • Kontakt:
          • Ola Nakken
      • Oslo, Norwegen
        • Rekrutierung
        • Oslo University Hospital
        • Hauptermittler:
          • Angelina Maniaol
        • Kontakt:
          • Angelina Maniaol
      • Sarpsborg, Norwegen, 1714
        • Noch keine Rekrutierung
        • Østfold Hospital Kalnes
        • Kontakt:
      • Stavanger, Norwegen
        • Rekrutierung
        • Stavanger University Hospital
        • Hauptermittler:
          • Katrin Ruth Schlüter
        • Kontakt:
          • Katrin Ruth Schlüter
      • Tromsø, Norwegen
        • Rekrutierung
        • Universitetssykehuset Nord-Norge
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Agnethe Eltoft, MD
        • Hauptermittler:
          • Monica Vold, MD
      • Trondheim, Norwegen
        • Rekrutierung
        • St. Olavs Hospital
        • Kontakt:
          • Eivind Brønstad, MD PhD
        • Hauptermittler:
          • Eivind Brønstad, MD PhD
    • Nordland
    • Vest Agder
      • Kristiansand, Vest Agder, Norwegen
        • Rekrutierung
        • Sørlandet Hospital Trust
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

8 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: ALS-Patienten, die sich für eine lebensverlängernde Behandlung mit LTMV entscheiden, und ihre Familien
Gerät: Long term mechanical ventilation support

Patients that choose life prolonging treatment with long term mechanical ventilation support
Aktiver Komparator: ALS-Patienten, die eine lebensverlängernde Behandlung mit LTMV ablehnen, und ihre Familien
Gerät: No long term mechanical ventilation support

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall quality of life assessed by the "Quality of Life Scale"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 21 months after inclusion

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Health-related quality of life assessed by the "EQ-5D-5L"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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)"
Zeitfenster: 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)"
Zeitfenster: 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)"
Zeitfenster: 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)"
Zeitfenster: 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)"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 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"
Zeitfenster: 21 months after inclusion

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Haukeland University Hospital

Mitarbeiter

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

Ermittler

  • Hauptermittler: Ole-Bjørn Tysnes, Haukeland University Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

21. April 2023

Primärer Abschluss (Geschätzt)

21. August 2032

Studienabschluss (Geschätzt)

21. August 2032

Studienanmeldedaten

Zuerst eingereicht

30. Januar 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Februar 2023

Zuerst gepostet (Tatsächlich)

27. Februar 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 492102

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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