Rheumatoid Arthritis Clinical Trial
— LIFTOfficial title:
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: A Randomised Clinical Trial
Verified date | September 2021 |
Source | University of Aberdeen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 368 |
Est. completion date | November 2, 2020 |
Est. primary completion date | November 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Grampian | Aberdeen | |
United Kingdom | NHS Tayside | Dundee | |
United Kingdom | NHS Lothian | Edinburgh | |
United Kingdom | NHS Greater Glasgow and Clyde | Glasgow | |
United Kingdom | Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle Upon Tyne | |
United Kingdom | Midlands Partnership NHS Foundation Trust | Stoke on Trent |
Lead Sponsor | Collaborator |
---|---|
University of Aberdeen | Versus Arthritis |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue (severity) using Chalder Fatigue Scale (Likert) | 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 | |
Primary | Fatigue (severity) using Chalder Fatigue Scale (Likert) | Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC | 10 weeks | |
Primary | Fatigue (severity) using Chalder Fatigue Scale (Likert) | Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC | 28 weeks | |
Primary | Fatigue (impact) using Fatigue Severity Scale | 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 | |
Primary | Fatigue (impact) using Fatigue Severity Scale | 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 | |
Primary | Fatigue (impact) using Fatigue Severity Scale | 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 | |
Secondary | Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire | Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire | 0, 10 weeks, 28 weeks, 56 weeks after randomisation | |
Secondary | Quality of life & health utility index | SF-12 | 0, 10 weeks, 28 weeks, 56 weeks after randomisation | |
Secondary | Pain using numerical rating scale | Pain numerical rating scale | 0, 10 weeks, 28 weeks, 56 weeks after randomisation | |
Secondary | Anxiety and depression using Hospital anxiety and depression scale | Hospital anxiety and depression scale | 0, 10 weeks, 28 weeks, 56 weeks after randomisation | |
Secondary | Impact on work using Work Productivity and Activity Impairment Questionnaire | Work Productivity and Activity Impairment Questionnaire: Specific Health Problem | 0, 10 weeks, 28 weeks, 56 weeks after randomisation | |
Secondary | Impact on activities using Valued Life Activities Scale | Valued Life Activities Scale | 0, 10 weeks, 28 weeks, 56 weeks after randomisation | |
Secondary | Change of global health | Single question to indicate perceived change in global health compared with last assessment visit | 10 weeks, 28 weeks, 56 weeks after randomisation |
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