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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Give incentives to physician based on their patient's HbA1c improvement; Behavioral: Give incentives to patients based on their own HbA1c improvement

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

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: incentives to physicians; Give incentives to physicians according to patients' HbA1c improvement	Behavioral: Give incentives to physician based on their patient's HbA1c improvement; Give incentives to physician based on their patient's HbA1c improvement
Experimental: incentives to patients; Give incentives to patients according to their HbA1c improvement	Behavioral: Give incentives to patients based on their own HbA1c improvement; Give incentives to patients based on their own HbA1c improvement
Experimental: incentives to both physicians and patients; intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement	Behavioral: Give incentives to physician based on their patient's HbA1c improvement; Give incentives to physician based on their patient's HbA1c improvement; Behavioral: Give incentives to patients based on their own HbA1c improvement; Give incentives to patients based on their own HbA1c improvement
No Intervention: Group with no incentives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Score on the Diabetes Quality Of Life		12 months
MEMS cap data compared to PHQ-9 and AIS assessment		12 months

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Ruijin Hospital
• Investigators: Study Chair: Liebin Zhao, MSM, Shanghai Clinical Centre for Endocrinology and Metabolism

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: December 24, 2014
• First Submitted That Met QC Criteria: December 31, 2014
• First Posted (Estimate): January 5, 2015

Study Record Updates

• Last Update Posted (Estimate): January 5, 2015
• Last Update Submitted That Met QC Criteria: December 31, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Community management， incentives, Medication Adherence
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CCEMD-026