Lessening the impact of fatigue in inflammatory rheumatic diseases v1
Research type
Research Study
Full title
Lessening the impact of fatigue in inflammatory rheumatic diseases: a randomised clinical trial
IRAS ID
216267
Contact name
Gary J Macfarlane
Contact email
Sponsor organisation
University of Aberdeen
Clinicaltrials.gov Identifier
Epi029, Epidemiology Group Study ID
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Summary of Research
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 the NHS. This situation results from the absence of standardised programmes and limited availability of relevant therapists. We aim to enhance access to fatigue alleviating physical activity and talking therapies by testing innovative, standardised and cost-effective approaches to treatment delivery.
We plan to recruit patients previously diagnosed with inflammatory rheumatic diseases such as rheumatoid arthritis who reported chronic fatigue, into a randomised controlled trial. They will be offered either a talking therapy, physical activity support or usual care alone and the interventions will be delivered to the participant via telephone or internet-based audio/video calls. There will be follow-up visits for up to 13 months after randomisation which will take place at a study centre close to the participants’ home.
We 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.
Summary of Results
Inflammatory rheumatic diseases include rheumatoid arthritis, lupus, and axial spondyloarthritis. Chronic fatigue can be a problem for patients with these diseases, but it is not managed well. Cognitive-behavioural treatment and personalised exercise programmes might be effective. They are not used much because it is not known how well they work for all these diseases. Additionally, regular face-to-face sessions might not be possible, especially during a pandemic. We wanted to know if these treatments could be helpful for fatigue in all these diseases. We particularly wanted to know if they worked when delivered by telephone.
We carried out a study to find out if the treatments could help patients with fatigue. We compared the treatments with the care patients would usually get. We carried out the study through hospitals in the UK. Patients took part in the study if they had any inflammatory rheumatic disease. They also had to have problems with fatigue. From September 2017 to September 2019, we recruited 368 patients to the study. We allocated patients to different treatments at random using a computer. We assigned patients to one of three groups. The groups were a cognitive-behaviour treatment, a personalised exercise programme, or usual care. Patients took sessions over 6 months. Health professionals with training in rheumatology gave the sessions. We measured the severity and impact of fatigue a year after starting treatment.
Patients in cognitive-behaviour and exercise groups improved more than those in usual care. The treatments delivered by telephone helped fatigue for different inflammatory rheumatic diseases. Doctors should think about using these treatments for managing fatigue in everyday practice.
REC name
Wales REC 7
REC reference
17/WA/0065
Date of REC Opinion
8 Mar 2017
REC opinion
Favourable Opinion