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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02330484
• Other study ID #: CCEMD-026
• Status: Active, not recruiting
• Phase: N/A
• First received: December 24, 2014
• Last updated: December 31, 2014
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 74 Years

Eligibility

Inclusion Criteria:

1. Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history

2. 40 to 74 years old

3. Diagnosis type 2 diabetes more than 6 months

4. Take at least one kind of oral hypoglycemic medication(including insulin injection)

5. Got treatment in community hospitals or follow up for more than 12 months

6. Have medical insurance

7. Stable condition with no adverse indication

8. Participate in this study voluntarily and sign the inform consent from

Exclusion Criteria:

1. Terminal illness

2. Serious hearing and visual disorder

3. Intend to receive selective surgery, to get pregnancy and breast feeding in three months

4. Demnentia or communication disorders

5. Mental disorders

6. The paralyzed or the handicapped

7. Expected survival time less than one-year

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

Intervention

Behavioral:
• Give incentives to patients based on their own HbA1c improvement
Give incentives to patients based on their own HbA1c improvement
• Give incentives to physician based on their patient's HbA1c improvement
Give incentives to physician based on their patient's HbA1c improvement

Locations

Country	Name	City	State
China	Ruijin hospital, Shanghai Jiao-Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Self-report medication adherence	The investigators assess adherence with MMAS 8-item version and BMQ-specific.	12 months	No
Secondary	Improvement of HbA1c		12 months	No
Secondary	Score on the Diabetes Quality Of Life		12 months	No
Secondary	MEMS cap data compared to PHQ-9 and AIS assessment		12 months	No