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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
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Based on patients' HbA1c improvement, this study aims to establish an incentive strategy to family physicians and patients respectively to evaluate the affect on the adherence to medication among patients with type2 diabetes.
First step: In this study, the investigators will conduct an open-label controlled randomized cluster trial to enroll 400 eligible and voluntary patients with type 2 diabetes from the community. 16 physicians will be involved in this study for patient management. Each physician will care at least 20 patients as a random unit which will be divided into 4 groups for baseline assessment including demographic characteristics, diabetes diagnosis and treatment, complication, biochemical indexes and self-management. The involved patients and physicians will receive related training. The patients will sign the informed consent form.
Second step: This study aims to give incentives to physicians or patients or both the physicians and patients based on HbA1c improvement. All the patients will sign the informed consent form. Regarding to the control group, health courses and community management will be given as usual. the investigators will evaluate the condition of patients' medication adherence after giving the incentives.
Third step: MEMS will be used in the intervention to monitoring patients' medication adherence. As a monitoring instrument, MEMS (Aardex, Zurich, Switzerland) is a plastic container with a spring-loaded device in the cap. Each time the bottles is opened for at least 3 seconds, the time and date of opening are recorded and saved. Based on the research data and the HbA1c improvement, this study will analyze the other factors which affect the patients' adherence to medication. Meanwhile, the investigators will collect patients' information such as blood pressure, biochemical index, complications related to diabetes, life quality, self-management, life style, health behavior, medications, health expenditure so as to evaluate the affect of incentive strategy on the adherence to medication among patients with type 2 diabetes.
Endpoint of the study:
The study will be ended in 12 months, endpoint measurement indicators are listed below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| incentives to physicians | Experimental | Give incentives to physicians according to patients' HbA1c improvement |
|
| incentives to patients | Experimental | Give incentives to patients according to their HbA1c improvement |
|
| incentives to both physicians and patients | Experimental | intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement |
|
| Group with no incentives | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Give incentives to patients based on their own HbA1c improvement | Behavioral | Give incentives to patients based on their own HbA1c improvement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data | MEMS will be used in the intervention to monitoring patients' medication adherence. As a monitoring instrument, MEMS (Aardex, Zurich, Switzerland) is a plastic container with a spring-loaded device in the cap. Each time the bottles is opened for at least 3 seconds, the time and date of opening are recorded and saved. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-report medication adherence | The investigators assess adherence with MMAS 8-item version and BMQ-specific. | 12 months |
| Improvement of HbA1c | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liebin Zhao, MSM | Shanghai Clinical Centre for Endocrinology and Metabolism | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin hospital, Shanghai Jiao-Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| Give incentives to physician based on their patient's HbA1c improvement | Behavioral | Give incentives to physician based on their patient's HbA1c improvement |
|
| Score on the Diabetes Quality Of Life | 12 months |
| MEMS cap data compared to PHQ-9 and AIS assessment | 12 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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