Inflammation plays a central role in atherosclerosis development and subsequent cardiovascular complications, including heart attack and stroke. Patients with inflammatory conditions such as community-acquired pneumonia (CAP) present with an elevated risk of cardiovascular events, which is likely driven by unresolved systemic inflammation. Targeting this heightened inflammatory burden may present a novel therapeutic strategy to attenuate heart attack risk in CAP survivors. Icosapent ethyl (IPE), an omega-3 fatty acid, demonstrates both pro-resolving and cardioprotective properties. The Targeting Vascular Inflammation In Patients with CAP (TIN-CAP) trial aims to evaluate the efficacy of IPE in mitigating vascular inflammation in CAP survivors.

TIN-CAP is a multicentre, randomised, double-blind, placebo-controlled trial. Eligible adults diagnosed with CAP in hospital or the emergency department will complete baseline assessments within 14 days of diagnosis including ¹⁸F-fluorodeoxyglucose (FDG) positron emission tomography/CT angiography, bloodwork and quality of life evaluation (EuroQol – 5 Dimensions (EQ-5D)). Participants will then be randomised 1:1 to receive IPE (4 g/day) or placebo for 6 months. Follow-up visits will occur at 30 days (bloodwork and EQ-5D only) and 6 months. The primary endpoint is the change in FDG uptake in the ascending aorta from baseline to 6 months between IPE and placebo groups. Secondary endpoints include FDG uptake in the bone marrow, spleen, lungs and other vasculature, in addition to major adverse cardiac events and quality of life assessments. An initial lead-in cohort of 18 patients will be enrolled to assess recruitment, imaging feasibility and IPE tolerability prior to full trial enrolment. These patients will remain blinded and will be included in the final analysis (Vanguard design).

The TIN-CAP trial has been approved provincially by the Clinical Trials Ontario Research Ethics Board (approval number: 5045). Participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations.

NCT06710080.

To determine the personal, National Health Service and wider societal resource use in relation to caring responsibilities for carers of people living with non-memory led dementias (NMLDs); and to design a resource use measure (RUM) that can be delivered in the Better Living with Non-memory-led Dementia (BELIDE) randomised controlled trial, part of the Rare Dementia (RD) - TALK research programme.

The first stage was to identify and review any existing RUMs that could be used or adapted to the trial population and setting. If no measures were identified, the second stage was initial informal discussions with healthcare professionals (HCPs) and the programme patient and public involvement representatives to inform the perspective, settings of care and main resource items to develop a new RUM. In the third stage, a first draft of the RUM was tested for content and face validity in a modified Delphi study comprising HCPs and carers. The measure was revised and, in the final stage, piloted in the first 3 months of the BELIDE trial to assess acceptability and feasibility of collecting the economic outcomes and the completeness of data collection. The key drivers of resource use and costs were assessed, and appropriate face validity checks were applied to ensure accurate description of the treatment pathways.

Carers and family of people living with NMLD recruited from Rare Dementia Support members in the UK, and a broad range of HCPs with experience of working with people who have NMLD to capture the different dimensions of experience, grade and skill mix.

In total, 20 people participated in the modified Delphi study, 11 HCPs and 9 carers. Rare Dementia Support groups and 1:1 calls were highly rated, as were general practitioner appointments. The greatest consensus was in the productivity and carer tasks; all caring tasks were highly rated. Healthcare practitioners rated healthcare items as higher importance than carers themselves.

Unpaid carers and HCPs are the experts in the resource impact of caring for someone with NMLD and have been underserved in research to date. This research, as part of preparatory stages of the BELIDE trial, has enabled the timely development of a comprehensive and valid RUM for unpaid carers of people with NMLD.

CRD42022356943.

NCT06241287.

Carers of people with non-memory-led dementias such as posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural variant frontotemporal dementia (bvFTD) face unique challenges. Yet, little evidence-based support and guidance are available for this population. To address this gap in services, we have developed a novel, web-based educational programme: the Better Living with Non-memory-led Dementia programme (BELIDE). BELIDE was co-designed with people with lived experience of non-memory-led dementia and a previous pilot study confirmed its feasibility as an online intervention. This protocol outlines the randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of BELIDE.

This is a parallel-group, single-blind, RCT of 238 unpaid caregivers of people diagnosed with PCA, PPA or bvFTD recruited internationally among members of the UK-based organisation Rare Dementia Support. The intervention (BELIDE programme) consists of six structured online educational modules tailored to each phenotype, a virtual onboarding session, real-life practice tasks and up to two follow-up facilitation sessions. The group receiving the intervention will be given access to the programme, while the control group will receive treatment as usual and be placed on a wait-list to receive access to the programme once they complete their participation in the trial. The allocation ratio will be 1:1 stratified by dementia diagnosis and gender. The primary outcome is reduction in caregiver depressive symptoms. Secondary outcomes include stress, anxiety, self-efficacy, quality of life and caregiver-patient relationship quality. Data will be collected online via Qualtrics surveys at baseline, 8 weeks and 6 months post-randomisation. A mixed-method process evaluation with a subgroup of intervention participants will explore barriers and facilitators for engagement. A health economics evaluation will also be conducted to assess cost-effectiveness. If effective, this programme could improve access to caregiver support for non-memory-led dementias by providing scalable, tailored education.

Ethical approval has been granted by University College London Research Ethics Committee (8545/007). The results will be disseminated via peer-reviewed publications, conferences, stakeholder events and open-access resources.

This trial has been registered prospectively on the Clinical Trials registry, first posted on 5 February 2024 under registration number NCT06241287.