Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases

Rheumatoid Arthritis Clinical Trial

— LIFT  

Official title:

Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: A Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248518
• Other study ID #: 2.049.16
• Secondary ID: Epi029
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: November 2, 2020

Study information

• Verified date: September 2021
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Collagen Diseases
• Fatigue
• Lupus Erythematosus, Systemic
• Psoriatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Sjogren's Syndrome
• Spondylarthritis

Intervention

Behavioral:
• Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
• 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
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	Versus Arthritis

Country where clinical trial is conducted

United Kingdom, 

Outcome

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

External Links

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