BACKGROUND: Although the Brazilian Unified Health System (SUS) offers universal health coverage, access to quality care is often limited by social inequality and location . Although telemedicine has been shown to be an important tool in the efforts to overcome this problem, because it can provide access to specialist care and break the geographical barriers to health care, there are no national studies demonstrating its use in public health .
OBJECTIVE: This study aims to test the hypothesis that remote consultation can be as effective as standard face-to-face consultation for type 2 diabetes mellitus in the Brazilian public health system and to assess the associated costs related to teleconsultation in public health scenarios, for patients referred from Primary Health Care units of the SUS for specialist care .
METHODS: This is a pragmatic, phase 2, unicentric, open-label, noninferiority, blinded allocation, data-blinded, centrally randomized clinical trial . The inclusion criteria will be adults, both sexes, ≥18 years old, glycated hemoglobin (HbA 1c) ≥8% . Outcomes will be evaluated by assessing symptoms, laboratory exams, anthropometric measurements, blood pressure, adverse events, and satisfaction level for 6 months . The costs of the teleconsultation will be assessed using the time-driven activity-based costing (TDABC) method to compare the costs with the face-to-face consultations . The noninferiority margin was set at 0.5% . Assuming an SD of 1.3% for both groups, true difference between the means of zero, and a type I error level of 5% (one-sided), it was estimated that 117 individuals per group would be necessary to achieve 90% power . Statistical analysis of the efficacy will be done using intention-to-treat and per-protocol approaches .
RESULTS: The results from this trial will be reported according to the CONSORT guidelines . The trial was approved by the institutional review board on October 5 , 2019 . Data collection started in January 2019 and is expected to finish in 2022 . At the time of manuscript submission, 18 participants were recruited .
CONCLUSIONS: Our expectations are that providing remote access to health care will result in improvements in the health and quality of life of patients with type 2 diabetes and reduce costs and that both patients and clinicians will benefit from and be satisfied with this technology .
TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos RBR-8gpgyd; https: //ensaiosclinicos.gov.br/rg/RBR-8gpgyd . INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23679.
Index: costs, diabetes mellitus, public health, remote consultation, telehealth, telemedicine