Stroke Circulatory System
Conditions
Interventions
This is a pilot study, exploring the feasibility and acceptability of the WAterS2 remote group intervention to support adjustment after stroke. The group intervention is informed by Acceptance and Com
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Staff inclusion criteria: 1. Can participate with clearance and support from their line manager 2. An understanding of the impact of stroke 3. Experience/knowledge of facilitating groups 4. Willing to be trained and adhere to research procedures Stroke survivor inclusion criteria: 1. Adults in the UK (at least 18 years old) 2. At least 4 months post-stroke (no upper limit) 3. Who identify as having unmet needs in terms of psychological adjustment to stroke 4. Sufficient English language to engage in groups/complete measures 5. Access to the internet and ability to engage in remote group intervention Supporting individual inclusion criteria: 1. Adults in the UK (over the age of 18 years) 2. Supporting a stroke survivor who is a participant in WAterS-2 3. Sufficient English language to engage in groups/complete measures 4. Capacity to consent
Exclusion criteria
Exclusion criteria: Staff exclusion criteria: 1. Not meeting the above inclusion criteria Stroke survivor exclusion criteria: 1. Lacking the capacity to consent 2. Stroke survivors who identify as severely anxious or depressed, or at risk of harm would be excluded from this research, and information on referral to appropriate expert psychological support will be provided Supporting Individual exclusion criteria: 1. Not meeting the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 20/03/2026: The primary aim of this study is to establish the feasibility and acceptability of the intervention and a future definitive trial. As such, most measures will relate to feasibility, collected and summarised by the end of the study period in time for write-up (approx. March 2026), such as: 1. Establishing recruitment pathways and workforce criteria in four test sites 2. Informing the recruitment and retention of a future fully-powered trial by establishing the number of participants identified, approached, consented, randomised and completed. 3. Refining future study procedures by establishing the acceptability and experience of the trial process to participants, including completion of outcome measures. 4. Determining the fidelity of delivery of the intervention through checklists and recordings 5. Determining the optimal primary outcome measure in future work by assessing the performance of selected candidate outcome measures with respect to the level of acceptability to participants (completion rates, perceived burden) and participant-perceived relevance and value. 6. Further assessing the acceptability of the treatment via qualitative interviews and more. Previous primary outcomes: The primary aim of this study is to establish the feasibility and acceptability of the intervention and a future definitive trial. As such, most measures will relate to feasibility, collected and summarised by the end of the study period in time for write-up (approx. June 2025), such as: 1. Establishing recruitment pathways and workforce criteria in three test sites 2. Informing the recruitment and retention of a future fully-powered trial by establishing the number of participants identified, approached, consented, randomised and completed. 3. Refining future study procedures by establishing the acceptability and experience of the trial process to participants, including completion of outcome measures. 4. Determining the fidelity of delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Some examples of measures that will be taken at timepoints are as follows: 1. At baseline: demographic and self-report clinical information related to the impact of impairments to cognition and language. 2. At baseline: research administered remote assessment of cognition and communication (this will be to establish, post hoc, whom this intervention might be best-suited for. It is not used to determine eligibility) In addition, the following Patient Reported Outcome Measures (PROMs) are repeated at baseline, after group intervention is completed, and again 3 months later: 3. Mood as recorded by the Hospital Anxiety and Depression Scale (HADS) 4. Wellbeing as recorded by Office of National Statistics 4 (ONS4) 5. Quality of life as recorded by EQ-5D-5L 6. Adjustment and acceptance as recorded by the Acceptance and Action Questionnaire for Acquired Brain Injury (AAQ-ABI) 7. Valued living as recorded by the Valuing Questionnaire (VQ) 8. Feedback questionnaires and qualitative interviews will also be conducted | — |
Countries
England, United Kingdom
Outcome results
None listed