Structured Diabetes Self-Management Education in Primary Care and Metabolic Control: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 主要终点
- HbA1c
研究概览
简要总结
Education is the mainstay of treatment of diabetes mellitus (DM), since it is through her that patients are trained to perform the management of your disease. There is a wide range of educational interventions tested in patients with DM, not having been defined so far a universal template that can be standardized and recognized as effective for all individuals with the disease. The present study aims to evaluate the effect of a group based structured education program, applied by a primary care generalist nurse, on metabolic control of type 2 diabetes mellitus (DM2) patients attending a primary care unit.
详细描述
Design: This was a single-center, parallel-group, randomized study Setting: One Primary Care Unit named Santa Cecília/Hospital de Clínicas de Porto Alegre Basic Unit of health, in Porto Alegre, Brazil.
Patients: Adult subjects (more than 18 years-old) up to the age of 80 years, with Type 2 diabetes, and with A1c >7%, regularly attending the primary care unit in the previous 6 months before the trial.
Exclusion criteria were: history of active infection (eg. osteomyelitis, pulmonary tuberculosis, AIDS), chronic corticosteroids use, unstable angina or myocardial infarction in the last 3 months, advanced renal disease require dialysis, heart failure (New York Heart Association class III and IV), cirrhosis, alcohol or illicit drug use, dementia, actual pregnancy or lactation, current cancer or any disease that might affect survival in the next 5 years.
Intervention: The intervention group (I) attended a five-week education course and reinforcement meetings every 4 months, for one year. The control group (C) received usual medical care.
Measures: Clinical (age, gender, ethnicity, history of hypertension and BP levels, smoking and physical activity), anthropometrical (weight, height, and waist circumference) and laboratorial data (fasting glucose levels, A1c, and lipid profile) The Diabetes knowledge was estimated by a questionnaire composed by 22 questions addressing the information discussed in the meetings and will be referred as type 2 DM knowledge score. This measures were done at 0, 4, 8 and 12 months End-points: The primary endpoint was changes in HbA1c at 4, 8 and 12 months. Additional analyses were done to evaluate changes in type 2 DM literacy, blood pressure (BP), body mass index (BMI) and lipids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •adult subjects (more than 18 years-old) up to the age of 80 years,
- •with DM2 (ref ADA), and with A1c >7%,
- •regularly attending a primary care unit in the previous 6 months
排除标准
- •history of active infection (eg. osteomyelitis, pulmonary tuberculosis, AIDS),
- •chronic corticosteroids use,
- •unstable angina or myocardial infarction in the last 3 months,
- •advanced renal disease require dialysis,
- •heart failure (New York Heart Association class III and IV),
- •cirrhosis,
- •alcohol or illicit drug use,
- •dementia,
- •actual pregnancy or lactation,
- •current cancer or any disease that might affect survival in the next 5 years.
研究组 & 干预措施
Structured Diabetes education
The intervention group received a structured DSME course. The course was composed by weekly 2 hour meetings for five weeks total hours group of 10 patient and reinforcement meetings every 4 months, for one year
干预措施: Structured Diabetes Education (Other)
结局指标
主要结局
HbA1c
时间窗: 4, 8 and 12 months
The primary endpoint was changes in HbA1c at 4, 8 and 12 months.
次要结局
- Changes in type 2 DM literacy.(4, 8 and 12 months)
- Changes in blood pressure (BP)(4, 8 and 12 months)
- Changes in Blood pressure(4, 8 and 12 months)
- Changes in body mass index (BMI)(4,8 and 12 months)
- Changes in Lipids(4,8 and 12 months)