Improvement of Care for Outpatients With Type 2 Diabetes Through Self-Care Multidisciplinary Workshop for Diabetes
2020年9月24日 更新者：Hospital de Clinicas de Porto Alegre
Improvement of Care for Outpatients With Type 2 Diabetes at the Porto Alegre Clinic Hospital Through Self-Care Multidisciplinary Workshop for Diabetes: a Randomized Controlled Trial
Ninety-six patients with diabetes will be randomly assigned to maintain standard treatment or participate in the Self-Care Multidisciplinary Workshop for Diabetes.
The workshop consists of individual meetings, with a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator and social worker) in which education and self-care topics will be approached aiming at the formation of knowledge and skills necessary for patient self-care.
The workshop will be offered in 3 different modules with 2 to 4 weeks difference between them.
The variation of glycated hemoglobin as well as aspects associated with self-care, adherence and quality of life will be evaluated at the study entry, 6 and 12 months later.
研究概览
详细说明
Ninety-six patients with type 2 diabetes from our Diabetes Outpatient Clinic will be randomly assigned to maintain standard treatment or participate in the Self-Care Multidisciplinary Workshop for Diabetes. The workshop consists of 15-minute individual meetings with each professional of a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator and social worker) in which education and self-care topics will be approached aiming at the formation of knowledge and skills necessary for patient self-care. The workshop will be offered in 3 different modules with 2 to 4 weeks difference between them.
Patients will be followed for 12 months. The variation of glycated hemoglobin as well as aspects associated with self-care, adherence and quality of life will be evaluated at the study entry, 6 and 12 months later.
研究类型
介入性
注册 (实际的)
96
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Rio Grande Do Sul
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Porto Alegre、Rio Grande Do Sul、巴西、90035-903
- Hospital de Clinicas de Porto Alegre
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with previous diagnosis of type 2 diabetes, HbA1c greater than 7.5% and age greater than 18 years
Exclusion Criteria:
- Types of diabetes other than type 2 diabetes; neurological, psychiatric or cognitive impairment that prevents proper understanding and participation in the workshop
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Workshop
Self-Care Multidisciplinary Workshop for Diabetes consist in individual meetings with a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator, physiotherapist and social worker) in which education and self-care topics will be approached.
The workshop will be offered in 3 different modules with 2-4 weeks difference between them.
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A 15-minute Individual meetings with each professional (nurse, pharmacist, nutritionist, physical educator, physiotherapist and social worker) of the multidisciplinary team in which diabetes education and self-care topics will be approached.
其他名称：
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有源比较器：Usual Care
Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.
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Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.
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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 |
|---|---|---|
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Change in glycated hemoglobin from baseline at 12 months
大体时间：12 months
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Variation of glycated hemoglobin
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in glycated hemoglobin from baseline at 6 months
大体时间：6 months
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Variation of glycated hemoglobin
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6 months
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Variation of Diabetes Quality of Life Questionnaire from baseline at 6 months
大体时间：6 months
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Diabetes Quality of Life Questionnaire
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6 months
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Variation of Diabetes Quality of Life Questionnaire from baseline at 12 months
大体时间：12 months
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Diabetes Quality of Life Questionnaire
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12 months
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Glycated hemoglobin equal or less than 8,0
大体时间：12 months
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Number of patients reaching glycated hemoglobin equal or less than 8,0
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12 months
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Glycated hemoglobin equal or less than 7,5
大体时间：12 months
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Number of patients reaching glycated hemoglobin equal or less than 7,5
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12 months
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Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 6 months
大体时间：6 months
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Change in SDSCA score 6 months after baseline
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6 months
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Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 12 months
大体时间：12 months
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Change in SDSCA score 12 months after baseline
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12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Beatriz DAgord Schaan, PhD、Hospital de Clinicas de Porto Alegre
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月20日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2019年3月1日
研究注册日期
首次提交
2017年2月24日
首先提交符合 QC 标准的
2017年3月3日
首次发布 (实际的)
2017年3月8日
研究记录更新
最后更新发布 (实际的)
2020年9月28日
上次提交的符合 QC 标准的更新
2020年9月24日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.