Effect of Holistic Management on the Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
short-term intensive education
Holistic management
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes, holistic management
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Education (Group A)
Education & holistic management(Group B)
Arm Description
short-intensive education for one month
short-intensive education for one month followed with holistic management for 6 months
Outcomes
Primary Outcome Measures
ADDQoL score at endpoint
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
Change of ADDQoL score between baseline and endpoint
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.
FPG at endpoint
All patients are examined for FPG at endpoint. FPG are determined by the hexokinase method.
PPG at endpoint
All patients are examined for PPG at endpoint. PPG are determined by the hexokinase method.
HbA1c at endpoint
All patients are examined for HbA1c at endpoint. HbA1c are determined by high performance liquid chromatography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03252080
Brief Title
Effect of Holistic Management on the Patients With Type 2 Diabetes
Official Title
Effect of Holistic Management on the Patients With Type 2 Diabetes Who Received or Did Not Receive a Short-term Intensive Education
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cheng Qing-feng
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
type 2 diabetes, holistic management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education (Group A)
Arm Type
Active Comparator
Arm Description
short-intensive education for one month
Arm Title
Education & holistic management(Group B)
Arm Type
Experimental
Arm Description
short-intensive education for one month followed with holistic management for 6 months
Intervention Type
Behavioral
Intervention Name(s)
short-term intensive education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Holistic management
Intervention Description
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 Measure Information:
Title
ADDQoL score at endpoint
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change of ADDQoL score between baseline and endpoint
Description
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.
Time Frame
6 months
Title
FPG at endpoint
Description
All patients are examined for FPG at endpoint. FPG are determined by the hexokinase method.
Time Frame
6 months
Title
PPG at endpoint
Description
All patients are examined for PPG at endpoint. PPG are determined by the hexokinase method.
Time Frame
6 months
Title
HbA1c at endpoint
Description
All patients are examined for HbA1c at endpoint. HbA1c are determined by high performance liquid chromatography.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
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Effect of Holistic Management on the Patients With Type 2 Diabetes
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