Community-led digitally-aided support system for cardiovascular disease prevention: starting in pregnancy extending to the family

Research questions 1. Can a multicomponent intervention improve women s cardiovascular risk in the first 12 months after a high-risk pregnancy/adverse pregnancy outcomes? 2. Can this approach be extended to other adult household members to screen, refer and manage undiagnosed cardiometabolic risk factors effectively? 3. What key factors are needed to implement and scale up this approach across the Caribbean and in other middle-income settings? Background Cardiovascular diseases are the leading cause of death in the Caribbean amongst both women and men. Women who develop pregnancy-related complications such as gestational diabetes and hypertensive disorders of pregnancy are at increased lifelong cardiometabolic risk. Evidence is lacking to guide clinical practice and policy on effective, scalable and sustainable programs to improve cardiometabolic health after pregnancy complications. Aim To adapt and test the implementation and effectiveness of SMARThealth, a multi-component, community-based, digitally-aided intervention to reduce cardiometabolic risk factors in postpartum women and adult household members in four Caribbean countries (Dominica, Guyana, Jamaica, and St. Vincent and the Grenadines). Methods 1. A co-design approach guided by Theory of Change model will be used to adapt the SMARThealth intervention. 2. A two-arm pragmatic cluster randomised trial of 852 postpartum women and 852 adult household members across 36 clusters (18 intervention, 18 control) across the four countries. The primary outcome is a change in Life s Essential 8 (LE8) (cardiometabolic risk) scores in the women between 6 weeks and 12 months post-delivery. Implementation outcomes will be assessed using the PRISM/RE-AIM framework. Eligible women will have one or more high-risk conditions during pregnancy or at birth, as defined by FIGO, plan to stay in the same location for the next 12 months, and provide informed consent. The SMARThealth intervention comprises (i) community health worker (CHW)/facilitator education, (ii) the SMARThealth tablet App for CHWs to aid the screening, detection, referral, and management of cardiometabolic risk factors in women and household members, and (iii) referral to primary care, with support for guideline-based prescribing, and ongoing support in the community for diet and lifestyle modification. Control clusters will receive the usual care. 3. Community engagement and involvement, with a program of co-designed activities to promote cardiometabolic health in women and household members; policy engagement and roundtables to define a Roadmap to sustainability and capacity development for researchers across the Caribbean. Timelines Year 1, the co-design phase to describe the causal processes for SMARThealth intervention, finalise the study design and training, and acquire ethical approval from all relevant institutions. Years 2-3 recruitment and implementation of the trial. Year 4, follow-up and final assessment of participants. Throughout the project (Years 1-4), ongoing process evaluation (qualitative and quantitative) and community engagement will occur. Year 5, dissemination of findings with local, national and international stakeholders, including ministries of health in each country and regional bodies. Anticipated impact This project will provide the first robust evidence for a practical, affordable, and contextually relevant approach to improving cardiometabolic risk factors disease in women after a high-risk pregnancy, benefitting households and health system capacity in under-resourced Caribbean communities.