跳至主要内容
临床试验/NCT05380596
NCT05380596Unknown不适用

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)

Rio Grande do Sul State Health Department - SES/RS2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
124
试验地点
2
主要终点
Adherence to treatment - Brief Medication Questionnaire (BMQ)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People aged 18 years or older, with a previous diagnosis of type 2 diabetes mellitus and who take dapagliflozin at the Special Medicines Pharmacy of the State of Rio Grande do Sul, Brazil, will be selected. In addition, it will be considered an inclusion criterion that the person is available to receive phone calls.

排除标准

  • Do not present a telephone record registered in the system;
  • Be participating in another diabetes education program;
  • Pregnancy;
  • Severe cognitive problems;
  • Communication difficulties;
  • Presence of other injuries;
  • Patients who are hospitalized at the time of recruitment will also be excluded from participation in this study.

结局指标

主要结局

Adherence to treatment - Brief Medication Questionnaire (BMQ)

时间窗: 3 months

Assessment of treatment adherence through the BMQ.

Variation in HbA1c levels

时间窗: 3 months

The patient'S blood glucose level

次要结局

  • Emergency visits(3 months)
  • Quality of life measured by DQOL-Brazil;(3 months)
  • Adherence to treatment(3 months)
  • Variation in blood pressure levels(3 months)
  • Variation in lipid profile(3 months)
  • Hospitalizations(3 months)
  • Medical consultations(3 months)
  • Drug-related problems(3 months)
  • Service-related cost(3 months)

研究者

发起方
Rio Grande do Sul State Health Department - SES/RS
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验