Mestrado em Assistência Farmacêutica

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Navegando Mestrado em Assistência Farmacêutica por Assunto "Ensaio clínico controlado aleatório"

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    Impacto do serviço de acompanhamento farmacoterapêutico nos desfechos em saúde de pacientes com hipertensão arterial: protocolo de ensaio clínico e dados preliminares
    (Universidade Federal do Espírito Santo, 2023-08-21) Vieira, Maria Paula Debona; Santos Junior, Genival Araújo dos; https://orcid.org/0000000256181846; http://lattes.cnpq.br/5917097187533724; https://orcid.org/0009-0003-0261-6239; http://lattes.cnpq.br/6124466867030276; Borba, Helena Hiemisch Lobo; https://orcid.org/0000-0001-9723-584X; http://lattes.cnpq.br/9205414489911034; Batista, Tatianne Mota; https://orcid.org/0000-0003-3240-2613; http://lattes.cnpq.br/2980899910202014
    Introduction: Hypertension is a chronic health condition that usually requires the use of medication; however, this use is not risk-free. In this scenario, medication therapy management. is a strategy that can improve the health outcomes of people with hypertension. Despite this, there are few studies with high scientific evidence on this topic. Objective: To evaluate preliminary data on the impact of the Comprehensive Medication Therapy service on the health outcomes of patients with hypertension. Methods: This study was carried out in two stages. The first consisted of the elaboration of a protocol for a randomized clinical trial, from June to December 2021. The second stage was the preliminary six-month evaluation of patients with hypertension. The patients who met the eligibility criteria were randomly allocated in a 1:1 ratio to the intervention or control group, who received medication therapy management and usual care, respectively, for 12 months. Both groups had their primary outcomes (baseline blood pressure and quality of life) and secondary outcomes (knowledge about pharmacotherapy; knowledge about hypertension and medication adherence; anthropometric profile, and clinical outcomes) assessed at two time points with a six-month interval between them. Ethical considerations were observed (CAAE: 13586319.6.0000.8151 | Approval nº 4.732.878). Statistical analyzes were performed using Student's t test for independent samples, investigating the difference in the means of the outcomes evaluated between the intervention and control groups at T0 (baseline) and T6. Results: In the first stage, a single-blind randomized clinical trial protocol was proposed, following the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials and the Consolidated Standards of Reporting Trials, which was registered in The Brazilian Clinical Trials Registry (ReBEC) (registration number RBR-4c53f3m). In the second stage, the preliminary evaluation showed that six months after the start of the study, no significant differences were found in any of the studied variables when comparing the control group and the intervention group. However, when performing intragroup analyses, it was possible to observe that patients in the intervention group had improvements in laboratory tests and quality of life after six months of follow-up, with a decrease in systolic blood pressure (-8.50 mmHg, p=0.04), total cholesterol (-11.94 mg/dL, p=0.05), and LDL (-12.21 mg/dL, p=0.01). They also had an increase in knowledge about hypertension (1.62, p=0.001), and improvement in quality of life (MINICHAL) in two parameters, mental (2.79 p=0.02) and somatic manifestations (1.62 p=0.03). Conclusion: In the preliminary 6-month analysis, statistically significant differences were found when comparing the control and intervention groups. The changes observed in the intervention group indicate a positive outcome related to the pharmacotherapeutic follow-up service, with the potential for further improvement in the results when the analysis is performed at 12 months.