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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: t
View:

• 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

• Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV

• Can communicate in Norwegian

• 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

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Nordland Hospital Bodø
RECRUITING
Bodø
Sørlandet Hospital Trust
RECRUITING
Kristiansand
Akershus University Hospital
RECRUITING
Lørenskog
Oslo University Hospital
RECRUITING
Oslo
Østfold Hospital Kalnes
NOT_YET_RECRUITING
Sarpsborg
Stavanger University Hospital
RECRUITING
Stavanger
Universitetssykehuset Nord-Norge
RECRUITING
Tromsø
St. Olavs Hospital
RECRUITING
Trondheim
Contact Information
Primary
Ole-Bjørn Tysnes
ole-bjorn.tysnes@helse-bergen.no
+ 47 55975063
Backup
Tale Litlere Bjerknes
tale.litlere.bjerknes@helse-bergen.no
+47 55975045
Time Frame
Start Date: 2023-04-21
Estimated Completion Date: 2032-08-21
Participants
Target number of participants: 200
Treatments
Active_comparator: 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
Sponsors
Collaborators: University Hospital of North Norway, St. Olavs Hospital, Oslo University Hospital, Helse Stavanger HF, University Hospital, Akershus, Østfold Hospital Kalnes, Hospital of Southern Norway Kristiansand, Nordland Hospital, Bodø
Leads: Haukeland University Hospital

This content was sourced from clinicaltrials.gov