Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases

NCT03248518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2021-09-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Usual Care

Information booklet on fatigue which represents usual care in almost all UK rheumatology centres

BEHAVIORAL

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

BEHAVIORAL

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.

Sponsors & Collaborators

  • Versus Arthritis

    collaborator OTHER
  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Gary Macfarlane, PhD · University of Aberdeen

  • Neil Basu, MBChB, PhD · University of Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2020-11-02
Completion
2020-11-02

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03248518 on ClinicalTrials.gov