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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| University Hospital, Akershus | OTHER |
| Helse Stavanger HF | OTHER_GOV |
| University Hospital of North Norway |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALS patients that choose life prolonging treatment with LTMV and their families | Active Comparator |
| |
| ALS patients that decline life prolonging treatment with LTMV and their families | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long term mechanical ventilation support | Device | Patients that choose life prolonging treatment with long term mechanical ventilation support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall quality of life assessed by the "Quality of Life Scale" | "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" | "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" | "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" | "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" | "Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life. | 21 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life assessed by the "EQ-5D-5L" | "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" |
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Inclusion criteria for patients:
Inclusion criteria for partners of ALS patients:
Inclusion criteria for children:
Exclusion criteria for patients, partners and children of ALS patients:
1. Potential participants with cognitive impairment or dementia.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ole-Bjørn Tysnes | Contact | + 47 55975063 | ole-bjorn.tysnes@helse-bergen.no | |
| Tale Litlere Bjerknes | Contact | +47 55975045 | tale.litlere.bjerknes@helse-bergen.no |
| Name | Affiliation | Role |
|---|---|---|
| Ole-Bjørn Tysnes | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordland Hospital Bodø | Recruiting | Bodø | Nordland | 8005 | Norway |
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| OTHER |
| St. Olavs Hospital | OTHER |
| Nordland Hospital, Bodø | UNKNOWN |
| Hospital of Southern Norway Kristiansand | UNKNOWN |
| Østfold Hospital Kalnes | UNKNOWN |
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| No long term mechanical ventilation support | Device | Patients that decline life prolonging treatment with long term mechanical ventilation support |
|
"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" | "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" | "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" | "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)" | "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)" | "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)" | "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)" | "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)" | "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" | "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" | "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" | "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" | "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" | "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" | "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" | "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" | "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" | "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" | "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" | "Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden). | At inclusion |
| Caregiver burden assessed by "Zarit Burden Interview" | "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" | "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" | "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" | "Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden). | 21 months after inclusion |
| Sørlandet Hospital Trust | Recruiting | Kristiansand | Vest Agder | Norway |
|
| Haukeland University Hospital | Recruiting | Bergen | Norway |
|
| Akershus University Hospital | Recruiting | Lørenskog | Norway |
|
| Oslo University Hospital | Recruiting | Oslo | Norway |
|
| Østfold Hospital Kalnes | Not yet recruiting | Sarpsborg | 1714 | Norway |
|
| Stavanger University Hospital | Recruiting | Stavanger | Norway |
|
| Universitetssykehuset Nord-Norge | Recruiting | Tromsø | Norway |
|
| St. Olavs Hospital | Recruiting | Trondheim | Norway |
|
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D016472 | Motor Neuron Disease |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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