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Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

2011年11月16日更新者：Vívian Saraiva Veras、University of Sao Paulo

Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home in Metabolic Control of People With Diabetes Mellitus

The self-monitoring of capillary blood glucose is part of the package of interventions in diabetes mellitus and an effective therapeutic strategy for the adequate control of the disease; and the continuing education of people with DM is recognized as one of the goals to delay the complications arising from chronic disease and alleviate the symptoms of hypoglycemia and hyperglycemia.

研究概览

地位

未知

条件

糖尿病

干预/治疗

详细说明

This study aims to evaluate the effects of educational intervention on self-monitoring of capillary blood glucose in metabolic control, knowledge and attitude in two groups of patients with diabetes mellitus: a group of diabetic patients who participate in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive educational interventions (Intervention Group - G1) and a group of diabetic patients who participle in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive conventional treatment (Control Group - G2). As an educational tool in diabetes will be used Conversation Maps which is considered an interactive program of diabetes education.

研究类型

介入性

注册 (预期的)

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

巴西
- São Paulo
  - Ribeirão Preto、São Paulo、巴西
    - 招聘中
    - University of Sao Paulo
    - 接触：
      
      Vívian Saraiva Veras, Principal Investigator
      
      电话号码：55 16 88074113
      
      邮箱：vivianveras@hotmail.com
    - 首席研究员：
      
      Vívian Saraiva Veras
    - 副研究员：
      
      Maria Lúcia Zanetti, Study Chair

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年至 90年 (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:

Ages 18 Years and older;
Diagnosis of type 1 and 2 diabetes mellitus;
In follow-up in the Self-Monitoring of Capillary Blood Glucose at Home Program;
Have cognitive conditions that enable participation (minimum ability of users to understand issues of data collection instruments, observation of the researcher and/or of the caregivers).

Exclusion Criteria:

Patients with gestational DM;
Patients with DM who are not located;
Those who die in the proposed period for the research;
Those who dropout the Self-Monitoring of Capillary Blood Glucose at Home Program;
Those who report difficulties to participate of the study due to work and those with amaurosis;
Used Conversation Maps as an educational tool.

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：支持治疗
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：日常护理	行为的：Usual Care Patients are followed in the medical appointments for evaluation and treatment of diabetes mellitus, according to service routine. Participants will be followed for an expected average of 12 weeks.
实验性的：Conversation Maps Diabetes Education	行为的：Conversation Maps Diabetes Education The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) how the body and diabetes works, 2) healthy eating and physical activity, 3) treatment with medication and monitoring blood glucose, and 4) reaching the targets with insulin (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program. Participants will be followed for an expected average of 12 weeks.

参与者组/臂

干预/治疗

有源比较器：日常护理

行为的：Usual Care

Patients are followed in the medical appointments for evaluation and treatment of diabetes mellitus, according to service routine. Participants will be followed for an expected average of 12 weeks.

实验性的：Conversation Maps Diabetes Education

行为的：Conversation Maps Diabetes Education

The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) how the body and diabetes works, 2) healthy eating and physical activity, 3) treatment with medication and monitoring blood glucose, and 4) reaching the targets with insulin (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program. Participants will be followed for an expected average of 12 weeks.

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：baseline, 3 and 6 months post intervention	Change from baseline in HbA1c at 6 months to less than 7%	baseline, 3 and 6 months post intervention

次要结果测量

结果测量	措施说明	大体时间
Diabetes Knowledge Questionnaire - DKN-A 大体时间：baseline, 3 and 6 months post intervention	Change from baseline in DKN-A at six months	baseline, 3 and 6 months post intervention
Diabetes Attitude Questionnaire - ATT-19 大体时间：baseline, 3 and 6 months post intervention	Change from baseline in ATT-19 at six months	baseline, 3 and 6 months post intervention

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。

赞助

University of Sao Paulo

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

2011年9月1日

初级完成 (预期的)

2011年12月1日

研究完成 (预期的)

2012年3月1日

研究注册日期

首次提交

2011年11月10日

首先提交符合 QC 标准的

2011年11月16日

首次发布 (估计)

2011年11月21日

研究记录更新

最后更新发布 (估计)

2011年11月21日

上次提交的符合 QC 标准的更新

2011年11月16日

最后验证

2011年11月1日

Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home