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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
124
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.
Rio Grande do Sul State Health Department - SES/RS
Porto Alegre, Rio Grande do Sul, Brazil
Variation in HbA1c levels
The patient'S blood glucose level
Time frame: 3 months
Adherence to treatment - Brief Medication Questionnaire (BMQ)
Assessment of treatment adherence through the BMQ.
Time frame: 3 months
Adherence to treatment
Assessed by the Self-Care Inventory - revised (SCI-R).
Time frame: 3 months
Variation in blood pressure levels
Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.
Time frame: 3 months
Variation in lipid profile
Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.
Time frame: 3 months
Hospitalizations
Number of hospitalizations in the period.
Time frame: 3 months
Medical consultations
Number of medical consultations performed.
Time frame: 3 months
Emergency visits
Number of emergency visits.
Time frame: 3 months
Drug-related problems
Number of drug-related problems found and resolved.
Time frame: 3 months
Service-related cost
Service-related cost
Time frame: 3 months
Quality of life measured by DQOL-Brazil;
Quality of life measured by Diabetes Quality of Life Measure (DQOL-Brasil).
Time frame: 3 months
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