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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
Cheng Qing-feng
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 3, 2017
    Last Updated
    August 14, 2017
    Sponsor
    Cheng Qing-feng
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    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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