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临床试验/NCT03252080
NCT03252080Unknown不适用

Effect of Holistic Management on the Patients With Type 2 Diabetes Who Received or Did Not Receive a Short-term Intensive Education

Cheng Qing-feng0 个研究点目标入组 200 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
ADDQoL score at endpoint

研究概览

简要总结

Two hundreds patients with T2DM from the outpatient clinic of The First Affiliated Hospital of Chongqing Medical University will be enrolled in this study. Participating subjects will be randomly assigned into one of the 2 groups: Group A (n=100) will be placed on the short-term intensive education program alone while Group B (n=100) will be placed on the short-term intensive education as well as a holistic management for 6 months.

Diabetes education: The patients of each group will undergo designated education programs in 4 subgroups. Group A and B will be given the same education classes once a week in the first month (total 4 times), 5 hours per class. The education classes will be taught by a dedicated team of diabetes specialist doctors and nurses, with the contents including a basic understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose monitoring. At the conclusion of the education classes, the patients in Group B then will undergo a weekly telephone interview with specialist nurses for 6 months to help patients resolve self-management problems while patients in Group A will not. The specialist nurses will talk individually with the patients in Group B for 10-15 min per week. The nurses will ask the patients about their results of self-blood glucose monitoring, help them find the reasons of poor blood glucose control as well as answer the patient's questions.

Clinical examination: All subjects will complete Audit of Diabetes Dependent Quality of Life (ADDQoL) before education classes commence (baseline), at 3 months and 6 months (endpoint) after education classes to evaluate their quality of life. All patients will be examined for height, weight, blood pressure, FPG, PPG and HbA1c at baseline, 3 months after education classes and endpoint. A diabetes specialist nurse will measure the height, weight and blood pressure, and assist the subjects to fill the questionnaire. FPG and PPG will be determined by the hexokinase method, while HbA1c by high performance liquid chromatography.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with T2DM for more than 1 year,
  • Age from 18 to 75 years old,
  • Have fasting plasma glucose (FPG) ≥ 7.2mmol/L or 2 hours postprandial plasma glucose (2hPPG) ≥ 10.0mmol/L,
  • Glycosylated hemoglobin (HbA1c) ≥ 7.0%,
  • Have the ability to self-care.

排除标准

  • Patients with severe liver or kidney dysfunction, severe heart failure, cognitive dysfunction or pregnancy will be excluded.

研究组 & 干预措施

Education (Group A)

Active Comparator

short-intensive education for one month

干预措施: short-term intensive education (Behavioral)

Education & holistic management(Group B)

Experimental

short-intensive education for one month followed with holistic management for 6 months

干预措施: short-term intensive education (Behavioral)

Education & holistic management(Group B)

Experimental

short-intensive education for one month followed with holistic management for 6 months

干预措施: Holistic management (Behavioral)

结局指标

主要结局

ADDQoL score at endpoint

时间窗: 6 months

All subjects complete Audit of Diabetes Dependent Quality of Life (ADDQoL) at endpoint to evaluate their quality of life. There are 13 items including Employment/career, Social life, Family relationships, Friends, Sex life, Sport/leisure, Travel, Future (own), Future of family, Motivation, Physical activities, Others fussing and Enjoyment of food. Each item is scored -3 to +3 (-3 = would be a great deal better if I did not have diabetes; +3 = would be a great deal worse if I did not have diabetes), yielding total between -39 to +39.

次要结局

  • FPG at endpoint(6 months)
  • Change of ADDQoL score between baseline and endpoint(6 months)
  • PPG at endpoint(6 months)
  • HbA1c at endpoint(6 months)

研究者

发起方
Cheng Qing-feng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cheng Qing-feng

Associate professor

Chongqing Medical University

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