Ongoing trial: Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases (LIFT)

Andy · Sep 23, 2019

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.
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At each of the four assessment visits (baseline, and approximately 2, 7 and 13 months after) they will be asked:

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

To provide a blood sample for research

To take part in an aerobic fitness test

To wear an activity monitor for the next 7 days which will be fitted at each visit

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.
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https://clinicaltrials.gov/ct2/show/NCT03248518

Also see, https://www.abdn.ac.uk/iahs/research/epidemiology/bsrbras-1286.php

Daisybell · Sep 23, 2019

@Jonathan Edwards - moving into rheumatology now.....
I see they are not calling it CBT and GET - but CBA and PEP (personalized exercise programme).
It’s like the spread of a contagion.

alktipping · Sep 23, 2019

so your'e sick and exhausted and these morons want to increase your'e daily workload with useless heavily biased report forms whilst keeping a daily diary that just reinforces how difficult your day to day experiences have become . would that not count as negative reinforcement and symptom focussing . talk about having your cake and eating it .

rvallee · Sep 23, 2019

Fatigue is not lack of motivation no matter how many drooling idiots insist otherwise. If you have to redefine the meaning of common words then you have failed before you even got started.

Up is red. Left means lilas. Pain means emotions. Who cares about the meaning of words? Let's just make stuff up and change the meaning of words.

James Morris-Lent · Sep 23, 2019

"Blood sample for research"

None of the outcomes listed have anything to do with blood markers.

Is that normal? Or just fishing for some random improvement in some cytokine or whatever that they can hype in the press release, or bury if it doesn't happen?

Sly Saint · Sep 24, 2019

Primary Outcome Measures

Fatigue (severity) using Chalder Fatigue Scale (Likert) [ Time Frame: 56 weeks ]
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

Fatigue (severity) using Chalder Fatigue Scale (Likert) [ Time Frame: 10 weeks ]
Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC

Fatigue (severity) using Chalder Fatigue Scale (Likert) [ Time Frame: 28 weeks ]
Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC

Fatigue (impact) using Fatigue Severity Scale [ Time Frame: 56 weeks ]
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

Fatigue (impact) using Fatigue Severity Scale [ Time Frame: 10 weeks ]
Fatigue Severity Scale, co-primary outcome assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC

Fatigue (impact) using Fatigue Severity Scale [ Time Frame: 28 weeks ]
Fatigue Severity Scale, co-primary outcome assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC

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no objective measures despite the activity monitors etc

study team https://www.abdn.ac.uk/iahs/research/epidemiology/bsrbras-1286.php#panel1308

TiredSam · Sep 24, 2019

It's about time someone did a study on the correlation between the use of a dodgy acronym in the title and the Chalder Fatigue Scale and a few of the usual psychobabbler names appearing in the study team. Correlation isn't causation, of course, but it might throw up a plausible hypothesis worthy of further investigation.

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Ongoing trial: Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases (LIFT)

Andy Committee Member

Daisybell Senior Member (Voting Rights)

alktipping Senior Member (Voting Rights)

rvallee Senior Member (Voting Rights)

James Morris-Lent Senior Member (Voting Rights)

Sly Saint Senior Member (Voting Rights)

TiredSam Committee Member

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Ongoing trial: Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases (LIFT)

Andy Committee Member

Daisybell Senior Member (Voting Rights)

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rvallee Senior Member (Voting Rights)

James Morris-Lent Senior Member (Voting Rights)

Sly Saint Senior Member (Voting Rights)

TiredSam Committee Member

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