Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
NCT ID: NCT03248518
Last Updated: 2021-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
368 participants
INTERVENTIONAL
2017-09-05
2020-11-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Usual Care alone
Participants receive written information about fatigue which is designed as self-management guide.
Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
CBA + usual care
In addition to usual care, participants receive a talking therapy using a cognitive behavioural approach. The talking therapy will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 8 sessions over a period of 6 months.
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
PEP + usual care
In addition to usual care, participants receive a personalised exercise programme. After an initial face-to-face assessment, the remaining programme will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 7 sessions over a period of 6 months.
Usual Care
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Versus Arthritis
OTHER
University of Aberdeen
OTHER
Responsible Party
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Principal Investigators
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Gary Macfarlane, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Aberdeen
Neil Basu, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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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, , United Kingdom
Countries
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References
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Gray SR, Montoye AHK, Vondrasek JD, Neph S, Siebert S, Paul L, Bachmair EM, Basu N. Associations of physical activity levels with fatigue in people with inflammatory rheumatic diseases in the LIFT trial. Rheumatol Adv Pract. 2024 Aug 24;8(3):rkae106. doi: 10.1093/rap/rkae106. eCollection 2024.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Click here for more information about this study
Other Identifiers
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Epi029
Identifier Type: OTHER
Identifier Source: secondary_id
2.049.16
Identifier Type: -
Identifier Source: org_study_id
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