Journal of evaluation in clinical practice · 2026
A Remote Chronic Disease Management Program to Improve Cardiovascular and Metabolic Outcomes in a Diverse Community-Based Diabetic Population: Study Design of the TAMIS Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Barros Renato de Carvalho, Stephanus Andrea, Filho José Antonio Barbosa, Mariana Evellyn, Botelho Yasmim, Severino Thaiene M M, Silva Robson Conceição, Almeida Lucila de Jesus, Koeche Cristiane, Gedeon Bruno, Oliveira Mariana Guimarães Souza de, Augusto Ana Carolina, Ferraz Catarina, Enzo F, Lima Gabriela de, Ibiapina Julia Andrade, Pinto Giselle, Ramalho Sérgio Henrique Rodolpho, Nogueira Ana Claudia C, Sposito Andrei C, Campos-Staffico Alessandra M, Soares Alexandre Anderson S M, Carvalho Luiz Sérgio F de
Аннотация
INTRODUCTION: Cardiovascular and cerebrovascular diseases are projected to expand in the coming decades as the main cause of death. This study outlines the escalating burden of cardiovascular diseases in low- and middle-income countries (LMICs), particularly in Latin America (LA), which is expected to surpass that of other high-population regions. Despite advances in prevention strategies, adherence to therapeutic goals remains a global challenge, especially in LMICs where control rates are notably low for conditions such as hypertension, type 2 diabetes mellitus (DM2), and dyslipidemia. Emerging evidence from LMICs supports the feasibility and effectiveness of telehealth interventions for cardiometabolic disease management in primary care.
AIMS: To address these challenges, a remote chronic disease management program has been developed to optimize risk factor control through standardized medical protocols and task automation.
METHODS: This is an open-label randomized and decentralized clinical trial describing the design and methodology of the TAMIS program, which will assess its impact on community-dwelling diabetic subjects with uncontrolled HBA1c and uncontrolled LDL-C and/or blood pressure. Individuals will be randomized to usual care or remote care and followed for 84 weeks. Remote monitoring offers a practical response to the limited capacity of LMIC health systems to ensure sustained follow-up and continuity of care for chronic conditions. The primary endpoint is a win-ratio of hierarchical events, including all-cause deaths and the frequency of all-cause hospitalizations. The secondary endpoints include control of HbA1c, LDL-C and blood pressure according to clinical guidelines, as well as patient-reported outcomes and clinical parameters, including blood pressure, glycemic control, and LDL cholesterol levels. Subgroup analyses will explore the impact of demographics and clinical characteristics on treatment outcomes. Overall, the study aims to improve health care delivery, enhance patient education, and foster collaboration between patients and health care providers to mitigate the growing burden of cardiovascular diseases in LMICs.
AIMS: To address these challenges, a remote chronic disease management program has been developed to optimize risk factor control through standardized medical protocols and task automation.
METHODS: This is an open-label randomized and decentralized clinical trial describing the design and methodology of the TAMIS program, which will assess its impact on community-dwelling diabetic subjects with uncontrolled HBA1c and uncontrolled LDL-C and/or blood pressure. Individuals will be randomized to usual care or remote care and followed for 84 weeks. Remote monitoring offers a practical response to the limited capacity of LMIC health systems to ensure sustained follow-up and continuity of care for chronic conditions. The primary endpoint is a win-ratio of hierarchical events, including all-cause deaths and the frequency of all-cause hospitalizations. The secondary endpoints include control of HbA1c, LDL-C and blood pressure according to clinical guidelines, as well as patient-reported outcomes and clinical parameters, including blood pressure, glycemic control, and LDL cholesterol levels. Subgroup analyses will explore the impact of demographics and clinical characteristics on treatment outcomes. Overall, the study aims to improve health care delivery, enhance patient education, and foster collaboration between patients and health care providers to mitigate the growing burden of cardiovascular diseases in LMICs.