POst Stroke Intervention Trial In Fatigue (POSITIF)

Launched by UNIVERSITY OF EDINBURGH · May 29, 2018

Keywords

ClinConnect Summary

Primary Objective

Does a brief cognitive behavioural intervention for post-stroke fatigue lead to clinically relevant improvements in fatigue after 6 months? Fatigue will be assessed using the self-reported Fatigue Assessment Scale (FAS) which has been validated for use in stroke (14). This scale includes both mental and physical fatigue. Our data shows that a difference of approximately 5 points in FAS was associated with a clinically significant difference in people with stroke (15); the literature on stroke patients suggests that a difference in four points on the scale is considered to...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Stroke 3 months to 2 years previously. Both ischaemic and haemorrhagic, including subarachnoid haemorrhage
• • Capacity to consent
• • Not living in nursing home.
• • Medically stable,
• • Answers 'Yes' to both the following questions about fatigue
• • 'Do you feel tired all the time or get tired very quickly since your stroke'?
• • Would you like additional help and support for this?
• Exclusion Criteria:
• • Unlikely to be available for follow-up for the next 6 months e.g. no fixed home address
• • Other life-threatening illness (e.g. advanced cancer or advanced heart failure) that will make survival for 6 months unlikely
• • Aphasia or cognitive impairment which is severe enough to prevent participation in the intervention. To assess this, patients will self-report their language and cognition from the relevant domains in the Short Stroke Impact Scale ('In the past week, how difficult was it for you to think quickly?' and 'In the past week, how difficult was it to understand what was being said to you in a conversation?') Those who respond 'very difficult' or 'could not do at all' to either question will be excluded. (24). Those who might be in these categories are likely to be unable to complete the form(s) and thus self-select to decline to return the paperwork.
• • Actively suicidal, requiring in-patient treatment for depression, depression related cognitive impairment. (see below)
• • High anxiety as part of a post-traumatic stress disorder syndrome or panic disorder (see below)
• • Previously enrolled in this trial
• • Enrolled in another talking therapy trial
• • Inability to understand spoken and/or written English