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Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases (LIFT)

2021年9月7日 更新者：University of Aberdeen

Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: A Randomised Clinical Trial

Fatigue is common and disabling for most patients with inflammatory rheumatic disease. Therapies designed to improve physical activity and 'talking' treatments, which positively help patients change the way they think and behave, are both helpful in reducing the burden of the fatigue. However, few patients have access to these treatments in most health services. This situation results from the absence of standardised programmes and limited availability of relevant therapists.

The investigators aim to enhance access to fatigue alleviating physical activity and talking therapies by testing innovative,standardised and cost-effective approaches to treatment delivery.

The investigators will also use this opportunity to understand how to select the best treatment for a patient based on their individual profile and to better understand how these treatments actually work. This in turn may lead to more refined and effective therapies in the future.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Eligible participants will be identified from patients with inflammatory rheumatic diseases attending major secondary care rheumatology services in the United Kingdom. Potential participants will be identified using local databases/clinic lists and will then be mailed a pre-study invite, which will include questions about fatigue. Potentially eligible participants will be invited to attend a baseline assessment.

Once it has been confirmed at the baseline assessement that they are eligible to take part in the study, the consented participant will be allocated to one of three treatment groups. During the course of the trial, the participant will be invited to visit the study centre three more times for assessments.

At each of the four assessment visits (baseline, and approximately 2, 7 and 13 months after) they will be asked:

  1. To complete questionnaires which collect information about various outcomes which we think will improve in response to the therapies under evaluation as well as factors which will help us understand how the treatments may work, and factors which may help identify those patients better suited to one therapy over another
  2. To provide a blood sample for research
  3. To take part in an aerobic fitness test
  4. To wear an activity monitor for the next 7 days which will be fitted at each visit
  5. To answer three short questions about engagement with intervention delivered by telephone from trial office at the time of session 4 and 8 (CBA and PEP intervention only). Similarly, the allocated therapists will be asked to give their view of the participants' engagement with the intervention.

All participants will be asked to keep a diary on any other treatments they are using in addition to the treatments they may receive during the study and how costly these other treatments are. The diary period will last for the first 6 months and then for 2 weeks after the third visit and 2 weeks before the last visit.

After they finished the study, the investigators may approach a subgroup of participants who received either the talking therapy or the personalised exercise programme again and ask for an interview to enable more detailed feedback on if they found the intervention helpful and how it has changed their daily life.

研究の種類

介入

入学 (実際)

368

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。

研究場所

  • イギリス
      • Aberdeen、イギリス
        • NHS Grampian
      • Dundee、イギリス
        • NHS Tayside
      • Edinburgh、イギリス
        • NHS Lothian
      • Glasgow、イギリス
        • NHS Greater Glasgow and Clyde
      • Newcastle Upon Tyne、イギリス、NE7 7DN
        • Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Stoke on Trent、イギリス、ST6 7AG
        • Midlands Partnership NHS Foundation Trust

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • be ≥ 18 years at the time of consent
  • have been diagnosed with rheumatoid arthritis (RA), systemic lupus erythematous (SLE), axial spondyloarthritis (AxSpA) or psoriatic arthritis (PSA) by a rheumatologist
  • report fatigue to be a persistent problem
  • have access to a telephone landline or mobile telephone and/or internet based audio/video calls
  • give permission for researchers to access their hospital medical notes
  • currently be under the care of a secondary care physician
  • have stable disease as evidenced by no change in immunomodulatory therapy within the last three months based on the hospital medical record

Exclusion Criteria:

  • there are significant abnormalities of thyroid function (TSH levels) on the most recent blood test done within the last three months
  • there is evidence of severe anaemia (haemoglobin levels) on the most recent blood test done within the last three months
  • there is evidence of severe renal dysfunction (eGFR) on the most recent blood test done within the last three months
  • they have a medical condition which would make the proposed interventions unsuitable, e.g. significant heart disease
  • they are pregnant
  • they are unable to understand English sufficiently to take part in the intervention
  • they are unable to provide written informed consent
  • they are not willing to be randomised
  • they are currently participating in an interventional clinical trial

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：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

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：Usual Care alone
Participants receive written information about fatigue which is designed as self-management guide.
行動：Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
アクティブコンパレータ：CBA + usual care
In addition to usual care, participants receive a talking therapy using a cognitive behavioural approach. The talking therapy will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 8 sessions over a period of 6 months.
行動：Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
行動：Cognitive behavioural approach
A talking therapy which explicitly aims to replace unhelpful beliefs and behaviours through the application of patient-centred strategies and behavioural activities
他の名前：
  • CBA
アクティブコンパレータ：PEP + usual care
In addition to usual care, participants receive a personalised exercise programme. After an initial face-to-face assessment, the remaining programme will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 7 sessions over a period of 6 months.
行動：Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
行動：Personalised Exercise Programme
PEP is a graded exposure behaviour therapy which aims to gradually optimise patients levels of physical activity with view to modifying their altered perception of effort and ultimately reduce the severity and impact of fatigue.
他の名前：
  • PEP

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
Fatigue (severity) using Chalder Fatigue Scale (Likert)
時間枠：56 weeks
Chalder Fatigue Scale (Likert), assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks after randomisation, Main estimate of treatment effect at 56 weeks
56 weeks
Fatigue (severity) using Chalder Fatigue Scale (Likert)
時間枠：10 weeks
Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
10 weeks
Fatigue (severity) using Chalder Fatigue Scale (Likert)
時間枠：28 weeks
Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
28 weeks
Fatigue (impact) using Fatigue Severity Scale
時間枠：56 weeks
Fatigue Severity Scale, co-primary outcome assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks
56 weeks
Fatigue (impact) using Fatigue Severity Scale
時間枠：10 weeks
Fatigue Severity Scale, co-primary outcome assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
10 weeks
Fatigue (impact) using Fatigue Severity Scale
時間枠：28 weeks
Fatigue Severity Scale, co-primary outcome assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
28 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
時間枠：0, 10 weeks, 28 weeks, 56 weeks after randomisation
Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Quality of life & health utility index
時間枠：0, 10 weeks, 28 weeks, 56 weeks after randomisation
SF-12
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Pain using numerical rating scale
時間枠：0, 10 weeks, 28 weeks, 56 weeks after randomisation
Pain numerical rating scale
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Anxiety and depression using Hospital anxiety and depression scale
時間枠：0, 10 weeks, 28 weeks, 56 weeks after randomisation
Hospital anxiety and depression scale
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Impact on work using Work Productivity and Activity Impairment Questionnaire
時間枠：0, 10 weeks, 28 weeks, 56 weeks after randomisation
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Impact on activities using Valued Life Activities Scale
時間枠：0, 10 weeks, 28 weeks, 56 weeks after randomisation
Valued Life Activities Scale
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Change of global health
時間枠：10 weeks, 28 weeks, 56 weeks after randomisation
Single question to indicate perceived change in global health compared with last assessment visit
10 weeks, 28 weeks, 56 weeks after randomisation

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

University of Aberdeen

協力者

Versus Arthritis

捜査官

  • 主任研究者：Gary Macfarlane, PhD、University of Aberdeen
  • 主任研究者：Neil Basu, MBChB, PhD、University of Glasgow

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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)

2017年9月5日

一次修了 (実際)

2020年11月2日

研究の完了 (実際)

2020年11月2日

試験登録日

最初に提出

2017年2月15日

QC基準を満たした最初の提出物

2017年8月11日

最初の投稿 (実際)

2017年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2021年9月16日

QC基準を満たした最後の更新が送信されました

2021年9月7日

最終確認日

2021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

  • 2.049.16
  • Epi029 (その他の識別子：Epidemiology Group, University of Aberdeen)

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

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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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