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ALS 患者とその家族の生活の質に対する長期換気サポートの効果 (ALS-LTMV)

2026年9月16日 更新者：Haukeland University Hospital

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

200

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • ノルウェー
      • Bergen、ノルウェー
      • Lørenskog、ノルウェー
        • 募集
        • Akershus University Hospital
        • 主任研究者：
          • Ola Nakken
        • コンタクト：
          • Ola Nakken
      • Oslo、ノルウェー
        • 募集
        • Oslo University Hospital
        • 主任研究者：
          • Angelina Maniaol
        • コンタクト：
          • Angelina Maniaol
      • Sarpsborg、ノルウェー、1714
        • まだ募集していません
        • Østfold Hospital Kalnes
        • コンタクト：
      • Stavanger、ノルウェー
        • 募集
        • Stavanger University Hospital
        • 主任研究者：
          • Katrin Ruth Schlüter
        • コンタクト：
          • Katrin Ruth Schlüter
      • Tromsø、ノルウェー
        • 募集
        • Universitetssykehuset Nord-Norge
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Agnethe Eltoft, MD
        • 主任研究者：
          • Monica Vold, MD
      • Trondheim、ノルウェー
        • 募集
        • St. Olavs Hospital
        • コンタクト：
          • Eivind Brønstad, MD PhD
        • 主任研究者：
          • Eivind Brønstad, MD PhD
    • Nordland
    • Vest Agder
      • Kristiansand、Vest Agder、ノルウェー
        • 募集
        • Sørlandet Hospital Trust
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

8年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：LTMVによる延命治療を選択したALS患者とその家族
デバイス：Long term mechanical ventilation support

Patients that choose life prolonging treatment with long term mechanical ventilation support
アクティブコンパレータ：LTMVによる延命治療を辞退するALS患者とその家族
デバイス：No long term mechanical ventilation support

Patients that decline life prolonging treatment with long term mechanical ventilation support

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Overall quality of life assessed by the "Quality of Life Scale"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：21 months after inclusion

"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
21 months after inclusion

二次結果の測定

結果測定
メジャーの説明
時間枠
Health-related quality of life assessed by the "EQ-5D-5L"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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)"
時間枠：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)"
時間枠：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)"
時間枠：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)"
時間枠：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)"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：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"
時間枠：21 months after inclusion

"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
21 months after inclusion

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Haukeland University Hospital

協力者

Oslo University Hospital
University Hospital of North Norway
Helse Stavanger HF
St. Olavs Hospital
University Hospital, Akershus
Nordland Hospital, Bodø
Hospital of Southern Norway Kristiansand
Østfold Hospital Kalnes

捜査官

  • 主任研究者：Ole-Bjørn Tysnes、Haukeland University Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年4月21日

一次修了 (推定)

2032年8月21日

研究の完了 (推定)

2032年8月21日

試験登録日

最初に提出

2023年1月30日

QC基準を満たした最初の提出物

2023年2月21日

最初の投稿 (実際)

2023年2月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月21日

QC基準を満たした最後の更新が送信されました

2026年9月16日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 492102

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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