Transient ischaemic attack, minor stroke, peripheral arterial disease Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/01/2025: 1. Male or female 2. =18–100 years of age 3. History of ischemic stroke National Institutes of Health Stroke Scale (NIHSS) score of less than 5 and/or 4. History of transient ischaemic attack and/or 5. Referral to Peripheral Vascular Clinic 6. Capacity to consent 7. Willingness to partake in a qualitative interview at the end of the intervention _____ Previous inclusion criteria: 1. (Identified as) male and female 2. =18–100 years of age 3. History of ischemic stroke National Institutes of Health Stroke Scale (NIHSS) score of less than 5 and/or 4. History of transient ischaemic attack and/or 5. Referral to Peripheral Vascular Clinic 6. Capacity to consent 7. Willingness to partake in a qualitative interview at the end of the intervention
Exclusion criteria
Exclusion criteria: 1. Less than 18 years of age 2. Patients receiving or eligible for palliative care 3. Unwillingness or inability (e.g. physical or cognitive) to comply with study procedures 4. Any person already participating in a clinical rehabilitation home intervention 5. Unwillingness to take part in a qualitative interview at the end of the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/01/2025: The feasibility of the Equality Health-CVD intervention will be ascertained through the following activities: 1. Recruitment and retention recorded during the following timepoints: baseline and 1, 4, 8, and 12 weeks post-baseline 2. The number and duration of contact visits, completion of the four intervention components, completion of data collection, the number of community and public service resources provided, and detailed descriptions of participants' social background, collected at various timepoints at 1, 4, 8, and 12 weeks post-baseline The researchers will also evaluate whether the following criteria progression have been met prior to planning a future large-scale trial: 1. Recruitment -% of target number of participants recruited (target: 20; 9 -month recruitment period) 2.Retention - % of patients who participate in 12-week follow-up (of those who complete min. 1 intervention session) 3.Feasibility of intervention implementation - The intervention is implemented with fidelity (i.e., 4 home visits conducted with data collected recorded at each visit and signposting to community and public assets. _____ Previous primary outcome measure: The feasibility of the Equality Health-CVD intervention will be ascertained through the following activities: 1. Recruitment and attrition recorded during the following timepoints: baseline and 1, 4, 8, and 12 weeks post-baseline 2. The number and duration of contact visits, completion of the four intervention components, completion of data collection, the number of community and public service resources provided, and detailed descriptions of participants' social background, collected at various timepoints at 1, 4, 8, and 12 weeks post-baseline The researchers will also evaluate whether the following criteria progression have been met prior to planning a future large-scale trial: 1. Number of participants offered the intervention and declined uptake during the consen | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The participants' acceptability and perception of the Equality Health-CVD Intervention, evaluated through qualitative semi-structured interviews at the end of the study 2. The deliverers' (Equality Health Advisors) acceptability of the intervention, including barriers and facilitators to delivery and perceived impacts of the intervention, evaluated using qualitative semi-structured interviews at the end of the study Participants will complete the following questionnaires baseline and 12 weeks post-baseline to support the evaluation within this feasibility study: 1. Self-reported physical, mental and social health measured using PROMIS 10 2. Social wellbeing measured using the South Wales Social Wellbeing Scale (SWSWBS) 3. Quality of life measured using EuroQol-5D The quantitative PROMS will be used in conjunction with qualitative semi-structured interviews as data descriptors. The aim is to assess whether the participants are willing and able to complete these measures, in addition to capturing subjective health and social wellbeing outcomes that may enhance data richness. | — |
Countries
United Kingdom, Wales