Disorders of lipoprotein metabolism and other lipidaemias
Conditions
Interventions
This is a prospective, randomized, open-label, controlled clinical trial aimed at determining the effect of a remote monitoring software for LDL cholesterol, blood glucose, and systemic arterial hyper
H02.403.840
Sponsors
Instituto de Ensino e Investigações Avançadas em Saúde
Fundação de Ensino e Pesquisa em Ciências da Saúde da Secretaria do Estado de Saúde do Distrito Federal
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients of both sexes; aged 18 years or older; patients followed by a physician within the Brazilian Primary Healthcare Network with at least one medical visit in the past three years; patients with diabetes and glycated hemoglobin (HbA1c) =7.0%, and with blood pressure and/or LDL-C above guideline-recommended targets
Exclusion criteria
Exclusion criteria: Patients deemed unsuitable for the program at the physician’s discretion; presence of any active underlying malignancy; participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate standard win ratio composed by time from randomization to the first occurrence of all-cause death and the frequency of non-fatal hospitalizations until week 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the time elapsed from randomization to the first occurrence of the following set of events: change in quality of life assessment after 84 weeks; adherence to home blood pressure measurements at 12, 56, and 84 weeks; prescription of antihypertensive, hypolipidemic, and hypoglycemic therapies at 12, 56, and 84 weeks, as well as adherence to these therapies during this period. | — |
Countries
Brazil
Contacts
Public ContactLuiz Sérgio de Carvalho
Instituto Aramari Apo
Outcome results
None listed