Reducing health inequalities: a place-based approach to supporting the wellbeing of vascular patients

Approved 11/09/2024, South East Scotland Research Ethics Committee 01 (2nd Floor, Waverley Gate, Edinburgh, EH1 3EG, United Kingdom; +44 (0)7814 764 241; Sandra.Wyllie@nhs.scot), ref: 24/SS/0067

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.

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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 consent process (≤20%)
2. Recruitment rate (≥80% of the target number of participants recruited within the first 5 months)
3. Follow-up completion (90-100% of participants complete the scheduled number of contact visits and 90-100% of participants complete the scheduled number of contact visits)
4. Attrition rate at the end of the study (25% drop out consider progression to RCT)
5. Completion of data collection (≥95% of required data points collected)

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.