Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Current interventions as of 25/04/2023:
The intervention will be delivered by NHS stroke services across the UK. NHS stroke services randomised to the intervention group will be trained to deliver the
Sponsors
Bradford Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 25/04/2023: All stroke survivors with the following characteristics are eligible for this trial: 1. Are aged 16 years or over at the time of stroke 2. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 3. Require manual contact of no more than one person to stand to prevent falling. Manual contact consists of continuous or intermittent light touch to assist balance or coordination (i.e. not to support body weight) 4. Planned discharge to live in the community (not to a care home) 5. Provide written informed consent or Consultee agreement Thus, the study will include a range of abilities from people who need help with balance/coordination to stand to those able to walk independently anywhere. Family/friends /carer will be eligible for the study provided they are: 1. Aged 16 years or over 2. A family member/close friend/carer of a stroke survivor participating in the study and identified by the stroke survivor as someone they engage with on a regular basis (meet at least once a fortnight) 3. Able and willing to provide written informed consent Previous participant inclusion criteria: All stroke survivors with the following characteristics are eligible for this trial: 1. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 2. Requires manual contact of no more than one person to stand to prevent falling. Manual contact consists of continuous or intermittent light touch to assist balance or coordination in keeping with Functional Ambulatory Categories [Holden et al, 1984] (FAC) 3-6 3. Planned discharge to live in the community (not to a care home) 4. Provide written informed consent or Consultee agreement Thus, the study will include a range of abilities from people who need help with balance/coordination to walk (FAC score=3) to those able to walk independently anywhere (FAC score=6) Family/friends /carer will be eligible for the study provided they are: 1. Aged 16 years or over 2. A family member/close friend/carer of a stroke survivor participating in the study and identified by the stroke survivor as someone they engage with on a regular basis (meet at least once a fortnight) 3. Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 25/04/2023: Stroke survivors will be excluded from the trial if they: 1. Are in receipt of palliative care 2. Are discharged outside the defined geographical area supported by the associated community service(s) participating in the trial Family members/friends/carers will be excluded from the trial if the person with stroke does not consent to the trial Previous participant exclusion criteria: Stroke survivors will be excluded from the trial if they: 1. Are in receipt of palliative care 2. Have an FAC score of 1 (unable to stand without the help of a hoist or two people) or an FAC score of 2 (need continuous support to walk), as they will be unable to amend their behaviour without substantial help 3. Are discharged outside the area supported by the associated community service(s) participating in the trial Family members/friends/carers will be excluded from the trial if the person with stroke does not consent to the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 25/04/2023: Participant-reported physical and social independence measured using the Nottingham Extended Activities of Daily Living scale (NEADL) at 12 months post-registration Previous primary outcome measure: Physical and social independence measured using the Nottingham Extended Activities of Daily Living (NEADL) at baseline, 6, 12 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/04/2023: Key secondary outcome measure: Sedentary behaviour (mean daily sedentary time in minutes) at 12 months, measured using an activity monitor (ActivPAL) Other secondary outcomes measured at baseline, 6-, 12- and 24- months post-registration (unless stated otherwise) for stroke survivor participants are: 1. EADLs measured by the Nottingham Extended Activities of Daily Living scale (NEADL) at baseline, 6 and 24 months 2. Sedentary behaviour measured by an activPAL activity monitor at baseline, 6, and 24 months 3. Physical and psychological functioning measured using the World Health Organisation Disability Assessment Schedule 2.0 (12-item; WHODAS 2.0-short) 4. Mental well-being measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) 5. Health status measured using the European Quality of Life 5-Dimension Health Questionnaire (5 levels; EQ-5D-5L) 6. Quality-Adjusted Life Year (QALY) gains 7. Fatigue measured using the Fatigue Assessment Scale (FAS) 8. Death 9. Falls and use of a walking aid at baseline, 12 weeks post-discharge, and at 6, 12 and 24 months 10. Use of a walking aid measured using participant-reported data at baseline, 12 weeks post-discharge, 6, 12 and 24 months 11. Self-reported sedentary behaviour measured using the Measure of Older Adults’ Sedentary Time (MOST) and a Sedentary Behaviour Visual Analogue Scale 12. Social participation measured using social questions 13. Self-reported health and social care service use and informal care inputs measured by a Client Services Receipt Inventory (CSRI) specifically adapted for this trial from versions used in previous stroke rehabilitation trials 14. Costs from a health and social care perspective, and a societal perspective that further includes informal care 15. Institutionalisation, hospital re-admission, and emergency department attendance rates at 6, 12 and 24 months 16. Cardiovascular risk markers: Height (baseline only) and weight fo | — |
Countries
England, United Kingdom
Outcome results
None listed