NCT05380596

TelePharmaceutical Care Diabetes Trial

Impact of TelePharmaceutical Care on People With Type 2 Diabetes Melitus, Seen at the Special Medicines Pharmacy of the State of Rio Grande do Sul: a Randomized Clinical Trial (TelePharmaceutical Care Diabetes Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Rio Grande do Sul State Health Department - SES/RS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of Diabetes Mellitus (DM) in the world is currently around 9.3% of adults aged between 20 and 79 years, which corresponds to 463 million people living with DM, and about 80% of these people are found in developing countries. In Brazil, fourth in the number of patients with Type 2 Diabetes Mellitus (DM2) in the world, the prevalence of DM is around 12%, with a significant increase in the last three decades. Non-adherence to DM treatment is known as a problem in the scenario and internationally, as it impairs the physiological response to the disease, increasing the direct and indirect cost of treatment. Pharmaceutical care is a practice model characterized by the provision of pharmaceutical services that optimize treatment, improve the process of medicines used, and aim at their best use. With the calamity situation arising from the COVID-19 pandemic created in the state of Rio Grande do Sul, the Pharmaceutical Telecare service was implemented. Dapagliflozin was recently incorporated into the Brazilian public system for the treatment of type 2 DM. Considering that there are no studies in Brazil to date on the use, treatment adherence, and problems related to pharmacotherapy (PRM) associated with dapagliflozin, and also considering that the guidance and monitoring of patients remotely have become more frequent and necessary, the purpose of this protocol is to describe a clinical trial that will evaluate the impact of a pharmaceutical telecare service in aspects related to treatment adherence, disease control, and costs, offered to people with DM2 using dapagliflozin. The hypothesis that will be tested is that Pharmaceutical Telecare can be as effective as standard care for type 2 diabetes and assess the associated costs related to teleconsultation in public health settings.

Conditions

• Diabete Mellitus
• Diabete Type 2
• Telemedicine
• Telehealth

Interventions

Type	Name	Description
BEHAVIORAL	Telepharmaceutical Care	The intervention will be carried out through three teleconsultations, one per month, with a pharmacist (Times 0, 1, 2 and 3). In the opportunities, aspects related to pharmacotherapy and health status, non-pharmacological approaches, treatment adherence and evaluation of problems related to pharmacotherapy (PRM) will be discussed.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2022-05-19
• Last updated: 2022-05-19

Locations

1 site across 1 country: Brazil