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Early testing of a supported self-management programme to help stroke survivors with aphasia and their families to develop strategies and confidence to manage life after stroke

Feasibility study of a supported self-management intervention for stroke survivors with aphasia (StarStep study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10401966
Enrollment
30
Registered
2022-10-07
Start date
2023-02-01
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

Based on a large programme of preliminary research which included working together with stroke survivors with aphasia, their family members and speech and language therapists, the researchers have dev

Sponsors

University of Leeds
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Stroke survivors with aphasia: 1. Are aged 16 years or over 2. Have a primary diagnosis of stroke 3. Have post-stroke aphasia (as diagnosed by the treating speech and language therapy service) 4. Are =12 months post-stroke 5. Are able and willing to provide informed consent for participating in data collection (e.g. questionnaires or observations or a semi-structured interview) or for whom a consultee declaration is provided (observations only) 6. Living at an address within the remit of a participating community service and referred for speech and language therapy from a participating community service Family members or friends: 1. Are aged 16 years or over 2. Are a family member/close friend and/or carer of a stroke survivor with aphasia participating in the study or are a family member/close friend and/or carer of a stroke survivor with aphasia who lacks the capacity to consent to participate in the study 3. Are a family member/close friend and/or carer who provides help and support (practical and/or emotional) to the stroke survivor with aphasia at least once a week 4. Are able and willing to provide informed consent Speech and language therapists: 1. Are employed as a speech and language therapist at a participating community stroke team 2. Has a caseload including stroke survivors with aphasia 3. Has received training in facilitating the self-management intervention 4. Are willing to provide informed consent to participate in the implementation group/observation of intervention delivery/semi-structured interview

Exclusion criteria

Exclusion criteria: Stroke survivors with aphasia: 1. >12 months post-stroke 2. Already in receipt of speech and language therapy from the community stroke team 3. In receipt of end-of-life care (documented in medical notes) 4. Residents in nursing or care homes 5. People with comorbid progressive neurological disorders, e.g. Huntington’s disease, motor neurone disease, Parkinson’s disease, multiple sclerosis Family members or friends: 1. They are caring for a stroke survivor resident in a nursing or care home or with palliative care needs 2. They are caring for a stroke survivor with a comorbid progressive neurological disorder e.g. Huntington’s disease, motor neurone disease, Parkinson's disease, or multiple sclerosis Speech and language therapists: Not applicable

Design outcomes

Primary

MeasureTime frame
1. The feasibility of recruitment methods and uptake, assessed using the number of stroke survivors with aphasia screened, identified as eligible and for whom informed consent/consultee declaration can be obtained at screening/consent 2. The feasibility of intervention implementation and delivery assessed using: 2.1. The feasibility of recruiting and training speech and language therapists to facilitate the intervention, assessed using training data (number of therapists trained compared to the number of therapists eligible for training within the service and a questionnaire assessing speech and language therapists' understanding of the intervention) at the end of training 2.2. Participants’ (stroke survivors with aphasia, family members/friends) views of the intervention (including acceptability, unanticipated consequences), assessed using in-depth qualitative interviews at 2 weeks after the end of the intervention 2.3. Facilitators’ (speech and language therapists) views of the intervention (including acceptability, barriers and enablers to implementation), assessed using in-depth qualitative interviews once therapists have finished their final sessions with participants recruited to the study 2.4. The fidelity of intervention delivery (including influencing contextual factors), assessed using a number of sources of data including observational data (observations of therapy sessions), quantitative data (cost and resource data/anonymised screening data) and qualitative data (from in-depth interviews and implementation groups) collected at all timepoints throughout the study (screening/consent/baseline/during intervention delivery/3 month follow-up) 2.5. The costs and resource use associated with delivering the intervention, assessed using an intervention log (detailing the number of sessions, therapy time, time spent preparing for sessions and travel time) collected during the intervention 3. The appropriateness of outcome measures assessed using the number of outc

Secondary

MeasureTime frame
Stroke survivors with aphasia: 1. Quality of life measured using the Stroke and Aphasia Quality of Life Scale (SA-QOL) 2. Symptoms of depression measured using the Patient Health Questionnaire-8 item (PHQ-8) 3. Perceived communication effectiveness measured using the Communicative outcomes after stroke (COAST) scale Family members/friends: 1. Levels of caregiver strain measured using the Caregiver Strain Index 2. Perceptions of their relatives/friends communication effectiveness measured using the Carer communicative outcomes after stroke (carer-COAST) scale 3. Perceptions of their relatives/friends symptoms of depression measured using the Stroke Aphasic Depression Questionnaire (SAD-Q-21). All measures will be collected at baseline and 3-month follow-up.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026