Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effekter av langsiktig ventilasjonsstøtte på livskvaliteten til ALS-pasienter og deres familier (ALS-LTMV)

16. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Norge
      • Bergen, Norge
      • Lørenskog, Norge
        • Rekruttering
        • Akershus University Hospital
        • Hovedetterforsker:
          • Ola Nakken
        • Ta kontakt med:
          • Ola Nakken
      • Oslo, Norge
        • Rekruttering
        • Oslo University Hospital
        • Hovedetterforsker:
          • Angelina Maniaol
        • Ta kontakt med:
          • Angelina Maniaol
      • Sarpsborg, Norge, 1714
        • Har ikke rekruttert ennå
        • Østfold Hospital Kalnes
        • Ta kontakt med:
      • Stavanger, Norge
        • Rekruttering
        • Stavanger University Hospital
        • Hovedetterforsker:
          • Katrin Ruth Schlüter
        • Ta kontakt med:
          • Katrin Ruth Schlüter
      • Tromsø, Norge
        • Rekruttering
        • Universitetssykehuset Nord-Norge
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Agnethe Eltoft, MD
        • Hovedetterforsker:
          • Monica Vold, MD
      • Trondheim, Norge
        • Rekruttering
        • St. Olavs Hospital
        • Ta kontakt med:
          • Eivind Brønstad, MD PhD
        • Hovedetterforsker:
          • Eivind Brønstad, MD PhD
    • Nordland
    • Vest Agder
      • Kristiansand, Vest Agder, Norge
        • Rekruttering
        • Sørlandet Hospital Trust
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: ALS-pasienter som velger livsforlengende behandling med LTMV og deres familier
Enhet: Long term mechanical ventilation support

Patients that choose life prolonging treatment with long term mechanical ventilation support
Aktiv komparator: ALS-pasienter som takker nei til livsforlengende behandling med LTMV og deres familier
Enhet: No long term mechanical ventilation support

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall quality of life assessed by the "Quality of Life Scale"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 21 months after inclusion

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health-related quality of life assessed by the "EQ-5D-5L"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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)"
Tidsramme: 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)"
Tidsramme: 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)"
Tidsramme: 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)"
Tidsramme: 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)"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 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"
Tidsramme: 21 months after inclusion

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Haukeland University Hospital

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Ole-Bjørn Tysnes, Haukeland University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. april 2023

Primær fullføring (Antatt)

21. august 2032

Studiet fullført (Antatt)

21. august 2032

Datoer for studieregistrering

Først innsendt

30. januar 2023

Først innsendt som oppfylte QC-kriteriene

21. februar 2023

Først lagt ut (Faktiske)

27. februar 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 492102

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere