Clinical trial NCT03248518: Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
Official title: Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lupus Erythematosus, Systemic
Axial Spondyloarthritis
Psoriatic Arthritis
Sjogren's Syndrome
Keywords: Inflammatory Rheumatic Disease
Fatigue
Exercise
Behavioural Intervention
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Axial Spondyloarthritis
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: Versus Arthritis
First posted: 2017-08-14
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue (severity) using Chalder Fatigue Scale (Likert)
timeFrame: 56 weeks
measure: Fatigue (severity) using Chalder Fatigue Scale (Likert)
timeFrame: 10 weeks
measure: Fatigue (severity) using Chalder Fatigue Scale (Likert)
timeFrame: 28 weeks
measure: Fatigue (impact) using Fatigue Severity Scale
timeFrame: 56 weeks
measure: Fatigue (impact) using Fatigue Severity Scale
timeFrame: 10 weeks
measure: Fatigue (impact) using Fatigue Severity Scale
timeFrame: 28 weeks
Secondary outcomes:
measure: Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
timeFrame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
measure: Quality of life & health utility index
timeFrame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
measure: Pain using numerical rating scale
timeFrame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
measure: Anxiety and depression using Hospital anxiety and depression scale
timeFrame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
measure: Impact on work using Work Productivity and Activity Impairment Questionnaire
timeFrame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
measure: Impact on activities using Valued Life Activities Scale
timeFrame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
measure: Change of global health
timeFrame: 10 weeks, 28 weeks, 56 weeks after randomisation
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Stoke on Trent
country: United Kingdom
facility: Midlands Partnership NHS Foundation Trust
Study officials:
affiliation: University of Aberdeen
name: Gary Macfarlane, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Neil Basu, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachmair EM, Martin K, Aucott L, Dhaun N, Dures E, Emsley R, Gray SR, Kidd E, Kumar V, Lovell K, MacLennan G, McNamee P, Norrie J, Paul L, Packham J, Ralston SH, Siebert S, Wearden A, Macfarlane G, Basu N; LIFT study group. Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial. Lancet Rheumatol. 2022 Jun 27;4(8):e534-e545. doi: 10.1016/S2665-9913(22)00156-4. eCollection 2022 Aug.
citation: Martin KR, Bachmair EM, Aucott L, Dures E, Emsley R, Gray SR, Hewlett S, Kumar V, Lovell K, Macfarlane GJ, MacLennan G, McNamee P, Norrie J, Paul L, Ralston S, Siebert S, Wearden A, White PD, Basu N. Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT). BMJ Open. 2019 Jan 30;9(1):e026793. doi: 10.1136/bmjopen-2018-026793.