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

7 septembre 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

368

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Usual Care alone
Participants receive written information about fatigue which is designed as self-management guide.
Comportemental: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Comparateur actif: 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.
Comportemental: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Comportemental: 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
Autres noms:
  • ABC
Comparateur actif: 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.
Comportemental: Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Comportemental: 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.
Autres noms:
  • DYNAMISME

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Aberdeen

Collaborateurs

Versus Arthritis

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 septembre 2017

Achèvement primaire (Réel)

2 novembre 2020

Achèvement de l'étude (Réel)

2 novembre 2020

Dates d'inscription aux études

Première soumission

15 février 2017

Première soumission répondant aux critères de contrôle qualité

11 août 2017

Première publication (Réel)

14 août 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 septembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 septembre 2021

Dernière vérification

1 septembre 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2.049.16
  • Epi029 (Autre identifiant: Epidemiology Group, University of Aberdeen)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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