Structured Diabetes Self-Management Education in Primary Care and Metabolic Control
Structured Diabetes Self-Management Education in Primary Care and Metabolic Control: a Randomized Clinical Trial.
研究概览
详细说明
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.
Statistical Analysis: Student t and chi-square test were used to compare baseline continuous and categorical variables, respectively. Variables with non-normal distribution were log transformed. Global linear model (GLM) for repeated measurements, with Bonferroni post-hoc test, was used to analyze changes in the outcomes during the trial. HbA1c values after the interventions were adjusted to baseline A1c and dosage of insulin at 12 months by ANCOVA. All patients with at least one A1c measurement available after randomization were included in the analyses, regardless if they attended all meetings of the education course or not (intention to treat analysis). A P value <0.05 (two-tailed) was considered significant.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的: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
|
The intervention group received a structured DSME course adapted from 15.
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
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
HbA1c
大体时间:4, 8 and 12 months
|
The primary endpoint was changes in HbA1c at 4, 8 and 12 months.
|
4, 8 and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Changes in type 2 DM literacy.
大体时间:4, 8 and 12 months
|
Additional analyses were done to evaluate changes in type 2 DM literacy.
|
4, 8 and 12 months
|
Changes in blood pressure (BP)
大体时间:4, 8 and 12 months
|
Knowledge of diabetes was estimated by a questionnaire consisting of 22 knowledge scores DM
|
4, 8 and 12 months
|
Changes in Blood pressure
大体时间:4, 8 and 12 months
|
The BP was measured twice with a digital sphygmomanometer (OMROM) with the patient in a sitting position, after a 5-min rest and with 1-min interval between measurements.
The value registered was the medium between two measures
|
4, 8 and 12 months
|
Changes in body mass index (BMI)
大体时间:4,8 and 12 months
|
The BMI (weight/height2) was calculated
|
4,8 and 12 months
|
Changes in Lipids
大体时间:4,8 and 12 months
|
The measure of fasting plasma total cholesterol, HDL and triglycerides were by enzymatic colorimetric method 20.
The Low-density lipoprotein cholesterol (LDL) was calculated by the formula of Friedwald equation (LDL = total cholesterol - HDL + Triglycerides/5).
|
4,8 and 12 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Structured Diabetes Education的临床试验
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne主动,不招人
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Helse Nord-Trøndelag HFNorwegian University of Science and Technology完全的