Clinical trial NCT03252080: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes
holistic management
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: ADDQoL score at endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Change of ADDQoL score between baseline and endpoint
timeFrame: 6 months
measure: FPG at endpoint
timeFrame: 6 months
measure: PPG at endpoint
timeFrame: 6 months
measure: HbA1c at endpoint
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: