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Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families (ALS-LTMV)

Primary Purpose

Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Nervous System Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Long term mechanical ventilation support
No long term mechanical ventilation support
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Quality of life, Overall quality of life, Health related quality of life, Disease specific quality of life, Ventilation support, Non-invasive ventilation support, Invasive ventilation support

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Haukeland University HospitalRecruiting
  • Akershus University Hospital
  • Oslo University HospitalRecruiting
  • Stavanger University Hospital
  • Universitetssykehuset Nord-Norge
  • St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ALS patients that choose life prolonging treatment with LTMV and their families

ALS patients that decline life prolonging treatment with LTMV and their families

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Caregiver burden assessed by "Zarit Burden Interview"
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Caregiver burden assessed by "Zarit Burden Interview"
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Caregiver burden assessed by "Zarit Burden Interview"
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Caregiver burden assessed by "Zarit Burden Interview"
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Caregiver burden assessed by "Zarit Burden Interview"
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).

Full Information

First Posted
January 30, 2023
Last Updated
September 18, 2023
Sponsor
Haukeland University Hospital
Collaborators
Oslo University Hospital, University Hospital, Akershus, St. Olavs Hospital, Helse Stavanger HF, University Hospital of North Norway
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1. Study Identification

Unique Protocol Identification Number
NCT05744310
Brief Title
Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families
Acronym
ALS-LTMV
Official Title
Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
August 21, 2032 (Anticipated)
Study Completion Date
August 21, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Oslo University Hospital, University Hospital, Akershus, St. Olavs Hospital, Helse Stavanger HF, University Hospital of North Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Nervous System Diseases, Spinal Cord Diseases, Neurodegenerative Diseases, TDP-43 Proteinopathies
Keywords
Quality of life, Overall quality of life, Health related quality of life, Disease specific quality of life, Ventilation support, Non-invasive ventilation support, Invasive ventilation support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALS patients that choose life prolonging treatment with LTMV and their families
Arm Type
Active Comparator
Arm Title
ALS patients that decline life prolonging treatment with LTMV and their families
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Long term mechanical ventilation support
Intervention Description
Patients that choose life prolonging treatment with long term mechanical ventilation support
Intervention Type
Device
Intervention Name(s)
No long term mechanical ventilation support
Intervention Description
Patients that decline life prolonging treatment with long term mechanical ventilation support
Primary Outcome Measure Information:
Title
Overall quality of life assessed by the "Quality of Life Scale"
Description
"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
Time Frame
At inclusion
Title
Overall quality of life assessed by the "Quality of Life Scale"
Description
"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
Time Frame
3 months after inclusion
Title
Overall quality of life assessed by the "Quality of Life Scale"
Description
"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
Time Frame
9 months after inclusion
Title
Overall quality of life assessed by the "Quality of Life Scale"
Description
"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
Time Frame
15 months after inclusion
Title
Overall quality of life assessed by the "Quality of Life Scale"
Description
"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
Time Frame
21 months after inclusion
Secondary Outcome Measure Information:
Title
Health-related quality of life assessed by the "EQ-5D-5L"
Description
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
Time Frame
At inclusion
Title
Health-related quality of life assessed by the "EQ-5D-5L"
Description
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
Time Frame
3 months after inclusion
Title
Health-related quality of life assessed by the "EQ-5D-5L"
Description
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
Time Frame
9 months after inclusion
Title
Health-related quality of life assessed by the "EQ-5D-5L"
Description
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
Time Frame
15 months after inclusion
Title
Health-related quality of life assessed by the "EQ-5D-5L"
Description
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
Time Frame
21 months after inclusion
Title
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Description
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
Time Frame
At inclusion
Title
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Description
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
Time Frame
3 months after inclusion
Title
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Description
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
Time Frame
9 months after inclusion
Title
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Description
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
Time Frame
15 months after inclusion
Title
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Description
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
Time Frame
21 months after inclusion
Title
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Description
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
Time Frame
At inclusion
Title
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Description
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
Time Frame
3 months after inclusion
Title
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Description
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
Time Frame
9 months after inclusion
Title
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Description
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
Time Frame
15 months after inclusion
Title
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Description
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
Time Frame
21 months after inclusion
Title
Health-related quality of life assessed by "Kidsscreen-27"
Description
"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.
Time Frame
At inclusion
Title
Health-related quality of life assessed by "Kidsscreen-27"
Description
"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.
Time Frame
3 months after inclusion
Title
Health-related quality of life assessed by "Kidsscreen-27"
Description
"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.
Time Frame
9 months after inclusion
Title
Health-related quality of life assessed by "Kidsscreen-27"
Description
"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.
Time Frame
15 months after inclusion
Title
Health-related quality of life assessed by "Kidsscreen-27"
Description
"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.
Time Frame
21 months after inclusion
Title
Caregiver burden assessed by "Zarit Burden Interview"
Description
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Time Frame
At inclusion
Title
Caregiver burden assessed by "Zarit Burden Interview"
Description
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Time Frame
3 months after inclusion
Title
Caregiver burden assessed by "Zarit Burden Interview"
Description
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Time Frame
9 months after inclusion
Title
Caregiver burden assessed by "Zarit Burden Interview"
Description
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Time Frame
15 months after inclusion
Title
Caregiver burden assessed by "Zarit Burden Interview"
Description
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
Time Frame
21 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ole-Bjørn Tysnes
Phone
+ 47 55975063
Email
ole-bjorn.tysnes@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Tale Litlere Bjerknes
Phone
+47 55975045
Email
tale.litlere.bjerknes@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole-Bjørn Tysnes
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole-Bjørn Tysnes
Phone
+4755975063
Email
ole-bjorn.tysnes@helse-bergen.no
Facility Name
Akershus University Hospital
City
Lørenskog
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola Nakken
First Name & Middle Initial & Last Name & Degree
Ola Nakken
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelina Maniaol
First Name & Middle Initial & Last Name & Degree
Angelina Maniaol
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Ruth Schlüter
First Name & Middle Initial & Last Name & Degree
Katrin Ruth Schlüter
Facility Name
Universitetssykehuset Nord-Norge
City
Tromsø
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margitta Kampmann
First Name & Middle Initial & Last Name & Degree
Margitta Kampmann
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene Kvernmo
First Name & Middle Initial & Last Name & Degree
Helene Kvernmo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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