CO-morbid Long-term disease Management in the Americas: blended intervention (COLMA)

To co-adapt/develop and evaluate the effectiveness, cost-effectiveness, and implementation of an Intervention Programme (IP) for people with comorbid depression, hypertension, and/or diabetes supported with a digital platform (DP) in primary care clinics (PCC) and their corresponding communities targeting socio-economically vulnerable populations in Peru and Argentina. Aims To gain a better understanding of the context, challenges, and enablers, to assist the co-adaptation/development of the intervention and identifying the appropriate implementation strategies of this IP embedded within PCC and communities. To co-adapt/develop this IP, including several components (health service and community interfaces and supportive DP) and implementation strategies followed by a brief feasibility study. To evaluate the effectiveness, cost-effectiveness, and implementation of this IP to improve the outcome of these three targeted comorbid chronic conditions, through a type 2 hybrid effectiveness-implementation study with two cluster randomised controlled trials in PCC and communities in Argentina and Peru. To deliver a comprehensive capacity building programme in both countries and an extended network in Latin American countries (LAC). Background Depression, hypertension, and diabetes lead the health burden in Peru and Argentina and across LAC. These conditions are often co-morbid, posing enormous challenges for the identification and effective treatment. Health care for people with comorbid chronic health problems in LAC is often limited and of low quality, something accentuated with the COVID-19 pandemic. There is a shortage of medical doctors and task shifting is the preferred implementation strategy to overcome this problem. Likewise, the interface between community and primary care is often patchy. Communities are frequently disempowered and lacking in support. Digital tools can support health services and communities and provide an option for help if another pandemic were to ensue. Digital tools have penetrated extensively in LAC; almost 80% of the population has a smartphone. Although the digital divide still exists, there has been a marked reduction across socio-economic groupings. We have developed effective treatment programmes for a range of physical and mental chronic conditions in several countries. We pioneered task-shifting for mental health in LAC and have been working with communities creating support groups for decades. We led several successful studies using digital tools to support the treatment of depression, hypertension, and diabetes in LAC. The project will last 60 months and is divided into four work packages (WP). Design and methods WP1 will use mostly qualitative methods and is guided by implementation frameworks. WP2 uses mixed methods (qualitative/quantitative) to co-adapt/develop the 3 main treatment components and implementation strategies of our proposed IP, using co-designed methodologies with intense stakeholder participation. WP3 will involve a brief feasibility study using mixed methods. WP4 will consist of two cluster-randomised controlled trial to compare clinical and implementation outcomes between the IP and a control group 12 months after entering the trials. The community will participate in the project from design to dissemination of results. There is a Co-I community leader , co-design involving community members, and community groups as part of our intervention. Dissemination will be wide and from the start to improve the likelihood of future sustainability.