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

7. September 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

368

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Usual Care alone
Participants receive written information about fatigue which is designed as self-management guide.
Verhalten: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Aktiver Komparator: 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.
Verhalten: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Verhalten: 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
Andere Namen:
  • CBA
Aktiver Komparator: 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.
Verhalten: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Verhalten: 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.
Andere Namen:
  • PEP

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Aberdeen

Mitarbeiter

Versus Arthritis

Ermittler

  • Hauptermittler: Gary Macfarlane, PhD, University of Aberdeen
  • Hauptermittler: Neil Basu, MBChB, PhD, University of Glasgow

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. September 2017

Primärer Abschluss (Tatsächlich)

2. November 2020

Studienabschluss (Tatsächlich)

2. November 2020

Studienanmeldedaten

Zuerst eingereicht

15. Februar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. August 2017

Zuerst gepostet (Tatsächlich)

14. August 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. September 2021

Zuletzt verifiziert

1. September 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2.049.16
  • Epi029 (Andere Kennung: Epidemiology Group, University of Aberdeen)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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