Effekter av långsiktigt ventilationsstöd på livskvaliteten för ALS-patienter och deras familjer (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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ole-Bjørn Tysnes
- Telefonnummer: + 47 55975063
- E-post: ole-bjorn.tysnes@helse-bergen.no
Studera Kontakt Backup
- Namn: Tale Litlere Bjerknes
- Telefonnummer: +47 55975045
- E-post: tale.litlere.bjerknes@helse-bergen.no
Studieorter
-
-
-
Bergen, Norge
- Rekrytering
- Haukeland University Hospital
-
Kontakt:
- Ole-Bjørn Tysnes
- Telefonnummer: +4755975063
- E-post: ole-bjorn.tysnes@helse-bergen.no
-
Lørenskog, Norge
- Rekrytering
- Akershus University Hospital
-
Huvudutredare:
- Ola Nakken
-
Kontakt:
- Ola Nakken
-
Oslo, Norge
- Rekrytering
- Oslo University Hospital
-
Huvudutredare:
- Angelina Maniaol
-
Kontakt:
- Angelina Maniaol
-
Sarpsborg, Norge, 1714
- Har inte rekryterat ännu
- Østfold Hospital Kalnes
-
Kontakt:
- Sophie Cranner Seip, MD
- Telefonnummer: +47 69 86 00 00
- E-post: Sophie.Cranner.Seip@so-hf.no
-
Stavanger, Norge
- Rekrytering
- Stavanger University Hospital
-
Huvudutredare:
- Katrin Ruth Schlüter
-
Kontakt:
- Katrin Ruth Schlüter
-
Tromsø, Norge
- Rekrytering
- Universitetssykehuset Nord-Norge
-
Kontakt:
- Agnethe Eltoft, MD
- Telefonnummer: +4777627075
- E-post: agnethe.eltoft@unn.no
-
Kontakt:
- Monica Vold, MD
- E-post: monica.linnea.vold@unn.no
-
Huvudutredare:
- Agnethe Eltoft, MD
-
Huvudutredare:
- Monica Vold, MD
-
Trondheim, Norge
- Rekrytering
- St. Olavs Hospital
-
Kontakt:
- Eivind Brønstad, MD PhD
-
Huvudutredare:
- Eivind Brønstad, MD PhD
-
-
Nordland
-
Bodø, Nordland, Norge, 8005
- Rekrytering
- Nordland Hospital Bodø
-
Kontakt:
- Ane Sjulstad, MD
- Telefonnummer: +47 75571000
- E-post: Ane.Skaare.Sjulstad@nordlandssykehuset.no
-
-
Vest Agder
-
Kristiansand, Vest Agder, Norge
- Rekrytering
- Sørlandet Hospital Trust
-
Kontakt:
- Hildegunn Øverlie, MD
- Telefonnummer: + 47 38073000
- E-post: hildegunn.overlie@sshf.no
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: ALS-patienter som väljer livsförlängande behandling med LTMV och deras familjer
|
Patients that choose life prolonging treatment with long term mechanical ventilation support |
|
Aktiv komparator: ALS-patienter som tackar nej till livsförlängande behandling med LTMV och deras familjer
|
Patients that decline life prolonging treatment with long term mechanical ventilation support |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall quality of life assessed by the "Quality of Life Scale"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 21 months after inclusion
|
"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life. |
21 months after inclusion
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Health-related quality of life assessed by the "EQ-5D-5L"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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)"
Tidsram: 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)"
Tidsram: 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)"
Tidsram: 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)"
Tidsram: 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)"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 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"
Tidsram: 21 months after inclusion
|
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden). |
21 months after inclusion
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ole-Bjørn Tysnes, Haukeland University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 492102
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .