Effect of Holistic Management on the Patients With Type 2 Diabetes

NCT ID: NCT03252080

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2018-07-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Education (Group A)

short-intensive education for one month

Group Type: ACTIVE_COMPARATOR

short-term intensive education

Intervention Type: BEHAVIORAL

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.

Education & holistic management(Group B)

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

Group Type: EXPERIMENTAL

short-term intensive education

Intervention Type: BEHAVIORAL

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.

Holistic management

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cheng Qing-feng

OTHER

Sponsor Role: lead

Responsible Party

Cheng Qing-feng

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

HMD2017

Identifier Type: -

Identifier Source: org_study_id