Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history
- •40 to 74 years old
- •Diagnosis type 2 diabetes more than 6 months
- •Take at least one kind of oral hypoglycemic medication(including insulin injection)
- •Got treatment in community hospitals or follow up for more than 12 months
- •Have medical insurance
- •Stable condition with no adverse indication
- •Participate in this study voluntarily and sign the inform consent from
排除标准
- •Terminal illness
- •Serious hearing and visual disorder
- •Intend to receive selective surgery, to get pregnancy and breast feeding in three months
- •Demnentia or communication disorders
- •Mental disorders
- •The paralyzed or the handicapped
- •Expected survival time less than one-year
研究组 & 干预措施
Group with no incentives
incentives to physicians
Give incentives to physicians according to patients' HbA1c improvement
干预措施: Give incentives to physician based on their patient's HbA1c improvement (Behavioral)
incentives to patients
Give incentives to patients according to their HbA1c improvement
干预措施: Give incentives to patients based on their own HbA1c improvement (Behavioral)
incentives to both physicians and patients
intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement
干预措施: Give incentives to patients based on their own HbA1c improvement (Behavioral)
incentives to both physicians and patients
intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement
干预措施: Give incentives to physician based on their patient's HbA1c improvement (Behavioral)
结局指标
主要结局
Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data
时间窗: 12 months
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.
次要结局
- Self-report medication adherence(12 months)
- Improvement of HbA1c(12 months)
- Score on the Diabetes Quality Of Life(12 months)
- MEMS cap data compared to PHQ-9 and AIS assessment(12 months)
研究者
Guang Ning
Professor
Shanghai Jiao Tong University School of Medicine