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临床试验/NCT03074383
NCT03074383已完成不适用

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

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Change in glycated hemoglobin from baseline at 12 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with previous diagnosis of type 2 diabetes, HbA1c greater than 7.5% and age greater than 18 years

排除标准

  • Types of diabetes other than type 2 diabetes; neurological, psychiatric or cognitive impairment that prevents proper understanding and participation in the workshop

结局指标

主要结局

Change in glycated hemoglobin from baseline at 12 months

时间窗: 12 months

Variation of glycated hemoglobin

次要结局

  • Variation of Diabetes Quality of Life Questionnaire from baseline at 6 months(6 months)
  • Glycated hemoglobin equal or less than 7,5(12 months)
  • Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 12 months(12 months)
  • Change in glycated hemoglobin from baseline at 6 months(6 months)
  • Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 6 months(6 months)
  • Variation of Diabetes Quality of Life Questionnaire from baseline at 12 months(12 months)
  • Glycated hemoglobin equal or less than 8,0(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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