Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title: Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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:

1. The study will be ended in 12 months

2. Patient's drop out of the study

3. Stopping taking oral hypoglycemic drugs

4. The diabetic condition worsen, needs surgery or hospitalization treatment

5. Frequency of severe hypoglycemia or other complications that can not continue the study

6. Death of the patient ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT02330484
• Study type: Interventional
• Source: Shanghai Jiao Tong University School of Medicine
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Completion date: June 2015