Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families

Amyotrophic Lateral Sclerosis Clinical Trial

— ALS-LTMV  

Official title:

Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744310
• Other study ID #: REK:492102
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: August 21, 2032

Study information

• Verified date: March 2023
• Source: Haukeland University Hospital
• Contact: Ole-Bjørn Tysnes
• Phone: + 47 55975063
• Email: ole-bjorn.tysnes[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 21, 2032
• Est. primary completion date: August 21, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Nervous System Diseases
• Neurodegenerative Diseases
• Spinal Cord Diseases
• TDP-43 Proteinopathies

Intervention

Device:
• Long term mechanical ventilation support
Patients that choose life prolonging treatment with long term mechanical ventilation support
• No long term mechanical ventilation support
Patients that decline life prolonging treatment with long term mechanical ventilation support

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Akershus University Hospital	Lørenskog
Norway	Oslo University Hospital	Oslo
Norway	Stavanger University Hospital	Stavanger
Norway	Universitetssykehuset Nord-Norge	Tromsø
Norway	St. Olavs Hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF, Oslo University Hospital, St. Olavs Hospital, University Hospital of North Norway, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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.	3 months after inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Caregiver burden assessed by "Zarit Burden Interview"	"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).	At inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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