Stroke Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of stroke or TIA occurring within 6-24 months prior to enrollment (first or recurrent) 2. Fatigue impacting on daily life, defined by answering “yes” to both of the Greater Manchester Stroke Assessment Tool fatigue questions: “Do you feel tired all the time or get tired very quickly since your stroke or mini-stroke (TIA)?” and “Would you like additional help and support for this?” 3. Adults aged >=18 years 4. Ability to understand English 5. Resident in catchment area for the sites 6. Ability to provide fully informed consent for participation in the study (with or without support)
Exclusion criteria
Exclusion criteria: 1. Taking part in a fatigue course within the past 12 months† 2. Diagnosis of dementia (identified from medical records*) 3. Receiving palliative care (identified from medical records*) † Note: For the purposes of exclusion, a formal course or programme delivered either online or in person would qualify as a ‘fatigue course’. This would not include ad hoc advice, or provision of information, e.g., a leaflet * Note: For participants who self-refer to the study, we will not have access to medical records; therefore, taking a pragmatic approach, these criteria will be self-confirmed by the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue severity measured using the Fatigue Severity Scale-7 (FSS-7) at baseline and 3-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatigue severity measured using a visual analogue scale (VAS) at baseline and 3 months 2. Confidence managing fatigue measured using a visual analogue scale (VAS) at baseline and 3 months 3. Impact of fatigue on communication ability measured using a visual analogue scale (VAS) at baseline and 3 months 4. Depression measured using the Patient Health Questionnaire (PHQ-8) at baseline and 3 months 5. Anxiety measured using the General Anxiety Disorder-7 (GAD-7) questionnaire at baseline and 3 months 6. Pain measured using a Visual Analogue Scale (VAS) at baseline and 3 months 7. Sleep measured using the Sleep Condition Indicator-02 (SCI-02) at baseline and 3 months 8. Physical activity measured using the International Physical Activity Questionnaire for The Elderly (IPAQ-E) at baseline and 3 months 9. Social participation measured using the PROMIS ability to participate in social roles and activities short form 6a at baseline and 3 months 10. Health-related quality of life measures using the EQ-5D-5L at baseline and 3 months 11. Capability and wellbeing measured using ICEpop CAPability measure for Adults (ICECAP-A) at baseline and 3 months 12. Work productivity/presentation measured using a single-item presenteeism question at baseline and 3 months 13. Healthcare resource measured through a bespoke health economics questionnaire at 3 months | — |
Countries
England, United Kingdom
Contacts
;