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Coproduction and evaluation of a self-management intervention for post-stroke fatigue

COproduction and evaluation of a self-MAnagemenT intervention for post-stroke Fatigue: Feasibility study (work package 4)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12086698
Enrollment
40
Registered
2026-07-28
Start date
2026-08-31
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Circulatory System

Interventions

The intervention consists of: 1. Rethink Fatigue – a digital self-management programme for post-stroke fatigue comprising of six core sessions delivered over 6 weeks, plus a caregiver session and addi

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

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

MeasureTime frame
Fatigue severity measured using the Fatigue Severity Scale-7 (FSS-7) at baseline and 3-month follow-up

Secondary

MeasureTime 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

Public ContactGrace;COMbAT Fatigue Turner;Study Team

;

G.Turner.1@bham.ac.uk;COMbATfatigueStudy@trials.bham.ac.uk-;+44 (0)121 415 9102

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026