Introduction Managing mood, cognition and fatigue are top unmet needs reported by stroke survivors, which impact quality of life. There is currently no standardised UK care pathway to support post-stroke psychological outcomes. The ENhanced Reviews of PsychologIcal Changes (ENRICH) programme, an intervention co-designed with stroke survivors, carers and healthcare professionals, aims to fill this gap. Here, we describe the protocol for evaluating the feasibility and acceptability of ENRICH.
Methods and analysis ENRICH reviews comprise cognition, mood and fatigue assessment, personalised psychoeducation and tools to communicate results and discuss self-management strategies, delivered at 1, 3 and 6 months post-stroke. N=140 participants (N=80 patients who had a stroke, N=45 carers, N=15 healthcare professionals) will be recruited to a single-arm multicentre feasibility study.
Patients who had a stroke and carers will complete demographics at baseline (T1) questionnaires of quality of life, mood and healthcare resource use at 6 months post-stroke (T2) and an optional interview on experiences of ENRICH. Process evaluation will include fidelity assessment via audio recordings. Descriptive statistics will be calculated for study outcomes.
Key qualitative acceptability outcomes are sought on intervention delivery by clinicians, patients and carers.
Key intervention delivery feasibility outcomes relate to training clinicians (including competency and fidelity delivering ENRICH), and review completion rates. Study feasibility outcomes will include site and participant recruitment and retention rates and completion of candidate primary outcome measures on quality of life.
Ethics and dissemination The ENRICH study was approved by a UK Research Ethics Committee (reference: 24/LO/0341). Consent procedures include a waiver of consent to the intervention itself due ENRICH’s service-level design and written informed consent/consultee advice for participants providing research data. Results will be disseminated through peer-reviewed publications, conferences and lay summaries for study participants and healthcare professionals. Results will inform whether ENRICH is acceptable to delivering clinicians and receiving patients who had a stroke and carers, and provide key insights to inform a future randomised trial to determine effectiveness.
Trial registration number ISRCTN16018388.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)