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

7 settembre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

368

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Usual Care alone
Participants receive written information about fatigue which is designed as self-management guide.
Comportamentale: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Comparatore attivo: 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.
Comportamentale: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Comportamentale: 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
Altri nomi:
  • ACB
Comparatore attivo: 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.
Comportamentale: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Comportamentale: 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.
Altri nomi:
  • PEP

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Aberdeen

Collaboratori

Versus Arthritis

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 settembre 2017

Completamento primario (Effettivo)

2 novembre 2020

Completamento dello studio (Effettivo)

2 novembre 2020

Date di iscrizione allo studio

Primo inviato

15 febbraio 2017

Primo inviato che soddisfa i criteri di controllo qualità

11 agosto 2017

Primo Inserito (Effettivo)

14 agosto 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 settembre 2021

Ultimo verificato

1 settembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2.049.16
  • Epi029 (Altro identificatore: Epidemiology Group, University of Aberdeen)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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