Effekter af langsigtet ventilationsstøtte på livskvaliteten for ALS-patienter og deres familier (ALS-LTMV)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ole-Bjørn Tysnes
- Telefonnummer: + 47 55975063
- E-mail: ole-bjorn.tysnes@helse-bergen.no
Undersøgelse Kontakt Backup
- Navn: Tale Litlere Bjerknes
- Telefonnummer: +47 55975045
- E-mail: tale.litlere.bjerknes@helse-bergen.no
Studiesteder
-
-
-
Bergen, Norge
- Rekruttering
- Haukeland University Hospital
-
Kontakt:
- Ole-Bjørn Tysnes
- Telefonnummer: +4755975063
- E-mail: ole-bjorn.tysnes@helse-bergen.no
-
Lørenskog, Norge
- Rekruttering
- Akershus University Hospital
-
Ledende efterforsker:
- Ola Nakken
-
Kontakt:
- Ola Nakken
-
Oslo, Norge
- Rekruttering
- Oslo University Hospital
-
Ledende efterforsker:
- Angelina Maniaol
-
Kontakt:
- Angelina Maniaol
-
Sarpsborg, Norge, 1714
- Ikke rekrutterer endnu
- Østfold Hospital Kalnes
-
Kontakt:
- Sophie Cranner Seip, MD
- Telefonnummer: +47 69 86 00 00
- E-mail: Sophie.Cranner.Seip@so-hf.no
-
Stavanger, Norge
- Rekruttering
- Stavanger University Hospital
-
Ledende efterforsker:
- Katrin Ruth Schlüter
-
Kontakt:
- Katrin Ruth Schlüter
-
Tromsø, Norge
- Rekruttering
- Universitetssykehuset Nord-Norge
-
Kontakt:
- Agnethe Eltoft, MD
- Telefonnummer: +4777627075
- E-mail: agnethe.eltoft@unn.no
-
Kontakt:
- Monica Vold, MD
- E-mail: monica.linnea.vold@unn.no
-
Ledende efterforsker:
- Agnethe Eltoft, MD
-
Ledende efterforsker:
- Monica Vold, MD
-
Trondheim, Norge
- Rekruttering
- St. Olavs Hospital
-
Kontakt:
- Eivind Brønstad, MD PhD
-
Ledende efterforsker:
- Eivind Brønstad, MD PhD
-
-
Nordland
-
Bodø, Nordland, Norge, 8005
- Rekruttering
- Nordland Hospital Bodø
-
Kontakt:
- Ane Sjulstad, MD
- Telefonnummer: +47 75571000
- E-mail: Ane.Skaare.Sjulstad@nordlandssykehuset.no
-
-
Vest Agder
-
Kristiansand, Vest Agder, Norge
- Rekruttering
- Sørlandet Hospital Trust
-
Kontakt:
- Hildegunn Øverlie, MD
- Telefonnummer: + 47 38073000
- E-mail: hildegunn.overlie@sshf.no
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion criteria for patients:
- 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
Inclusion criteria for partners of ALS patients:
- Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV
- Can communicate in Norwegian
Inclusion criteria for children:
- 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
- Can communicate in Norwegian
Exclusion criteria for patients, partners and children of ALS patients:
1. Potential participants with cognitive impairment or dementia.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: ALS-patienter, der vælger livsforlængende behandling med LTMV og deres familier
|
Patients that choose life prolonging treatment with long term mechanical ventilation support |
|
Aktiv komparator: ALS-patienter, der afslår livsforlængende behandling med LTMV og deres familier
|
Patients that decline life prolonging treatment with long term mechanical ventilation support |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ole-Bjørn Tysnes, Haukeland University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 492102
Plan for individuelle deltagerdata (IPD)
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