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Effect of Holistic Management on the Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03252080
Recruitment Status : Not yet recruiting
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Cheng Qing-feng, Chongqing Medical University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: short-term intensive education Behavioral: Holistic management Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Holistic Management on the Patients With Type 2 Diabetes Who Received or Did Not Receive a Short-term Intensive Education
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Education (Group A)
short-intensive education for one month
Behavioral: short-term intensive education
The patients of both groups are given the education classes once a week in the first month (total 4 times), 5 hours per class. The education classes are 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.

Experimental: Education & holistic management(Group B)
short-intensive education for one month followed with holistic management for 6 months
Behavioral: short-term intensive education
The patients of both groups are given the education classes once a week in the first month (total 4 times), 5 hours per class. The education classes are 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.

Behavioral: Holistic management
The specialist nurses talk individually with the patients for 10-15 min per week. The nurses 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.




Primary Outcome Measures :
  1. ADDQoL score at endpoint [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change of ADDQoL score between baseline and endpoint [ Time Frame: 6 months ]
    All subjects complete Audit of Diabetes Dependent Quality of Life (ADDQoL) at baseline and 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. The change of ADDQoL score between baseline and endpoint = the total score of ADDQoL at endpoint - the total score of ADDQoL at baseline.

  2. FPG at endpoint [ Time Frame: 6 months ]
    All patients are examined for FPG at endpoint. FPG are determined by the hexokinase method.

  3. PPG at endpoint [ Time Frame: 6 months ]
    All patients are examined for PPG at endpoint. PPG are determined by the hexokinase method.

  4. HbA1c at endpoint [ Time Frame: 6 months ]
    All patients are examined for HbA1c at endpoint. HbA1c are determined by high performance liquid chromatography.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Responsible Party: Cheng Qing-feng, Associate professor, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03252080     History of Changes
Other Study ID Numbers: HMD2017
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cheng Qing-feng, Chongqing Medical University:
type 2 diabetes
holistic management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases