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

NCT ID: NCT02330484

Last Updated: 2015-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-06-30

Brief 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.

Detailed 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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

incentives to physicians

Give incentives to physicians according to patients' HbA1c improvement

Group Type: EXPERIMENTAL

Give incentives to physician based on their patient's HbA1c improvement

Intervention Type: BEHAVIORAL

Give incentives to physician based on their patient's HbA1c improvement

incentives to patients

Give incentives to patients according to their HbA1c improvement

Group Type: EXPERIMENTAL

Give incentives to patients based on their own HbA1c improvement

Intervention Type: BEHAVIORAL

Give incentives to patients based on their own HbA1c improvement

incentives to both physicians and patients

intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement

Group Type: EXPERIMENTAL

Give incentives to patients based on their own HbA1c improvement

Intervention Type: BEHAVIORAL

Give incentives to patients based on their own HbA1c improvement

Give incentives to physician based on their patient's HbA1c improvement

Intervention Type: BEHAVIORAL

Give incentives to physician based on their patient's HbA1c improvement

Group with no incentives

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Give incentives to patients based on their own HbA1c improvement

Give incentives to patients based on their own HbA1c improvement

Intervention Type: BEHAVIORAL

Give incentives to physician based on their patient's HbA1c improvement

Give incentives to physician based on their patient's HbA1c improvement

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Guang Ning

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liebin Zhao, MSM

Role: STUDY_CHAIR

Shanghai Clinical Centre for Endocrinology and Metabolism

Locations

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CCEMD-026

Identifier Type: -

Identifier Source: org_study_id