None listed
Conditions
Brief summary
Fatigue is a common and persistent deficit in up to 92% of stroke survivors that can negatively impact functioning. It is imperative that new strategies be developed to tackle post-stroke fatigue, a debilitating but often overlooked sequelae of stroke. Cognitive and behavioural (educational) interventions for fatigue have been successful in other conditions (e.g. traumatic brain injury, multiple sclerosis, chronic fatigue syndrome), but have not been fully examined in the context of stroke. Building on promising findings from our pilot study, this full-scale randomised controlled trial aims to assess the effect of the intervention on reducing physical, psychological and mental fatigue and improving quality of life in stroke survivors. Family carer quality of life and burden, as well as impact of the intervention on other functional outcomes and costs will also be examined. This trial has potential to improve quality of life and day-to-day functioning for stroke survivors and their families.
Interventions
Following written informed consent, participants will be randomly assigned to receive either a single 90 minute Usual Care (UC) group session or six weekly standardised fatigue management group (FMG) sessions of 60 to 90 minutes duration per week. FMG sessions will focus on fatigue management, sleep, exercise, nutrition and mood. Participants will receive a study-specific handouts to accompany each session, and will be asked to complete a fatigue and activity diary. Across both groups, all sessions will be run by registered clinical psychologists (or similar appropriately registered health professionals) using a brief cognitive behavioural therapy framework already tested in an earlier pilot trial. While caregivers will not attend sessions, they will also receive a handouts containing all the information covered in the respective group. All participants across both groups (and nominated family caregivers where available) will complete an in-person baseline assessment, with follow-up assessments directly after the completion of group session/s and at 3-months later. Each assessment is expected to take no longer than 60 minutes for adults with stroke, and 20 minutes for each participating family caregiver. All assessments will be administered by a research assistant 'blinded' to group status. All intervention group sessions will be delivered by registered personnel trained in the delivery of either the intervention or usual care group session. All participants will provide informed written consent before attending any groups session or the collection of any study data. There will be no testing of new medical devices or treatments. The brief CBT framework, altered to accommodate cognitive deficiencies common post-stroke, will emphasise compensatory strategies (i.e. energy conservation) given likely organic factors linked to PSF. This professionally guided process recognises the expertise of the group members, validates their experiences, and enables the sharing of knowledge, reflection, and experiences. Behaviour change will be achieved by goal setting, planning, and trialling fatigue management strategies in the home and community. Standardised data collection will be achieved using a systematic competency assessment with all research assistants and clinical psychologists to be delivered and monitored by study management. On-going training and feedback will ensure sustained quality of the trial. To monitor clinical psychologists’ adherence to FMG and GSE treatment regime and fidelity, group sessions will be audio-recorded with participant’s consent and a random 10% will be independently assessed by two CBT experts. Potential therapist effects will be minimised by each clinical psychologist being trained in the delivery of either the FMG or GSE sessions. A standardised CBT quality criteria instrument will also assess adherence to CBT, FMG and GSE delivery, with additional training provided if required. Participant adherence to protocol will be monitored via diary data, session attendance, and reviews at each session.
Sponsors
Study design
Eligibility
Inclusion criteria
To be eligible to take part in the study, potential participants must meet the following criteria: (a) CT/MRI confirmed stroke to enable exclusion of stroke-mimic conditions; (b) clinically significant fatigue at 3 to 24-months after stroke; (c) residing in the study areas (Auckland, Waikato) to ensure feasibility; (d) ability to converse in English to support understanding of group discussions and materials; and (e) able to provide informed consent.
Exclusion criteria
Pre-stroke fatigue, given differing aetiology requiring a different intervention approach; significant cognitive (MMSE <23 or Montreal Cognitive Assessment <26) or behavioural impairments (e.g. agitation, major depressive criteria measured by the CES-D revised - depression scale); significant disability (mRS 4-5) due to high dependence for basic Acitivities of Daily Living making some Fatigue Severity Scale (FSS) items not applicable (i.e. ‘my fatigue prevents sustained physical functioning) making it difficult to accurately detect changes in fatigue; identified causes of chronic fatigue (e.g. sleep apnea); medical instability, or other health condition (e.g. dementia, drug/alcohol abuse) that would preclude full participation; and participation in another clinical trial.