Pharmaceutical Care Program for Users of Brazilian Public Health Care System With Type 2 Diabetes Mellitus: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- GLYCATED HEMOGLOBIN (A1C) LEVELS
研究概览
简要总结
The purpose of this study is to examine the effect of a pharmaceutical care program on the level of glycated hemoglobin for hyperglycemic users of brazilian public health care system in drug treatment for type 2 diabetes.
详细描述
The chronic diseases, including diabetes mellitus (DM) are a major public health problems of today. There is evidence that glycated hemoglobin (A1C) levels above 7% are associated with a progressively greater risk of chronic complications related to DM. However, approximately 60% of diabetics do not achieve glycemic control. In Brazil, pharmacists are not involved in direct care of patients with DM. The investigators conducted a randomized controlled trial, for six months, in Ouro Preto, Minas terais to determine the effect of pharmaceutical intervention on glycemic control in patients with diabetes and hyperglycemic (A1C > 7%). One hundred and twenty-nine subjects were randomized to receive usual care only or usual care and pharmaceutical intervention. The population of those who had access in the brazilian public health care system, as consultations with doctors, nurses and nutritionists, laboratory tests and access to essential medicines were considered as conventional health care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •MINIMAL AGE 18 YEARS OLD
- •USE OF DIABETES ORAL MEDICATION
- •MINIMAL GLYCOHEMOGLOBIN 7%
排除标准
- •PREGNANT AND NURSING WOMEN
- •PEOPLE UNABLE TO ATTEND THE STUDY SITE
- •PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE
结局指标
主要结局
GLYCATED HEMOGLOBIN (A1C) LEVELS
时间窗: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample
次要结局
- FASTING GLUCOSE LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- TOTAL CHOLESTEROL LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- LDL CHOLESTEROL LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- HDL CHOLESTEROL LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- SYSTOLIC BLOOD PRESSURE LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- TRIGLYCERIDES LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- DIASTOLIC BLOOD PRESSURE LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))