Effectiveness of Pharmacotherapy Follow-up Care in Outpatients With Type 2 Diabetes Mellitus: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- hospitalization
研究概览
简要总结
Hypothesis: Pharmacotherapy follow-up can improve clinical outcomes of outpatients with type 2 diabetes mellitus.
Methods: In this single blind, placebo-controlled trial, the participants with type 2 diabetes mellitus are randomized into two groups:
- pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and
- control (n=30, attended by the usual procedure of dispensing).
Primary outcomes evaluated are: hospitalization (percentage of participants hospitalized), severe evolving complication - ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion (presence or absence).
Other parameter checked: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure (BP), total cholesterol (TC), waist circumference (WC), body mass index (BMI) and mortality. The investigators follow up all patients for up to 12 months.
详细描述
Background. Few Brazilian randomized controlled trials have established the benefits of pharmacotherapy follow-up in care of outpatients with type 2 diabetes mellitus in low-middle income country. This study evaluate the effectiveness of pharmacotherapy follow-up care to get better outcomes in outpatients with type 2 diabetes mellitus attended in the public health service in Brazil.
Method: In this single blind, placebo-controlled trial, the investigators random patients with type 2 diabetes mellitus into two groups: 1) pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and 2) control (n=30, attended by the usual procedure of dispensing).
Primary outcomes checked are: percentage of hospitalization, severe evolving complication (ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy and evolving foot lesion).
The investigators also check: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure (BP), total cholesterol (TC), HbA1c/BP, HbA1c/TC, waist circumference (WC), body mass index (BMI) and mortality. The participants are followed up to 12 months.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previous diagnosis of type 2 diabetes, HbA1c greater than 7% and age greater than 18 years
排除标准
- •Types of diabetes other than type 2 diabetes; patients not responsible for administering their drugs and patients with mental deficits that could no understand the study.
结局指标
主要结局
hospitalization
时间窗: in 12 months
percentage of participants hospitalized due to diabetes
次要结局
- severe evolving complication (ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion)(in 12 months)
研究者
Luciane Cruz Lopes
PhD
University of Sorocaba